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| ID | Type | Description | Link |
|---|---|---|---|
| CRO-17-133 | Other Identifier | CROSS Research S.A. |
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| Name | Class |
|---|---|
| Cross Research S.A. | INDUSTRY |
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This is a phase II, single centre, randomised, parallel-group, double-blind, three doses, placebo-controlled, exploratory efficacy and safety study. The objective of this study is to investigate the efficacy and safety of a single intrathecal injection of Paracetamol 3% (30 mg/mL) administered at 3 doses to 3 active treatment groups, as compared to placebo, for post-operative analgesia in knee procedures up to 40 min duration performed under spinal anaesthesia with Chloroprocaine HCl 1%.
Eligible patients undergoing elective short-duration knee procedures up to 40 min duration will be randomised into 4 treatment groups (15 patients per group) to receive either one of the 3 single doses of Paracetamol 3% (D1: 30 mg, D2: 60 mg, D3: 90 mg) or the placebo solution (P: 0.9% saline solution) by intrathecal injection (IT), according to the randomised, parallel-group design.
Immediately after IT paracetamol or placebo administration, all patients will receive a single IT dose of Chloroprocaine HCl 1% (Non-investigational medicinal product, NIMP) according to the Summary of Product Characteristics indications. The time interval between paracetamol IT and chloroprocaine IT injections should not exceed 2 min.
The study will include a screening phase (Visit 1, Day -21/-1), a treatment phase (IMP IT administration, anaesthesia and surgical procedure: Visit 2, Day 1) and a follow-up phase including an observation period (Visit 3), a final visit and two follow-ups (24 h post-dose and day 7±1).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 mg Paracetamol 3% (1 mL) | Experimental | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) |
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| 60 mg Paracetamol 3% (2 mL) | Experimental | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) |
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| 90 mg Paracetamol 3% (3 mL) | Experimental | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) |
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| Placebo, 0.9% saline solution | Placebo Comparator | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 30 mg Paracetamol 3% (1 mL) | Drug | Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity at Rest Evaluated Using a 0-100 mm VAS | The study primary efficacy measures will be the VAS scores at each predefined time-point after the anaesthetic intrathecal injection until eligibility for home discharge ( VAS scale is 0-100 mm, where 0 is no pain and 100 is maximum pain) | Pain intensity at rest evaluated using a 0-100 mm VAS at baseline (within 30 min before NIMP IT injection, 0 h), 1, 1.25, 1.5, 1.75, 2 h after NIMP IT injection, then every 30 min after NIMP IT injection until eligibility for home discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at Rest AUCt1-t2 | AUC t1-t2 is defined as the area under the pain intensity curve at the specified time-intervals | Up to 4 hours after injection |
| Pain at Rest AUClast | AUClast is defined as the area under the pain intensity curve from 0 h up to the last assessment time |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Neurological Complications Including TNS | Number of Participants with Neurological Complications Including TNS at 24 h post-dose and at day 7±1 | From anaesthetic intrathecal injection up to day 7±1 (i.e. 6±1 days after analgesic/anaesthetic IT injection and surgery) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio Camponovo, MD | Department of Anaesthesiology, Clinica Ars Medica, Via Cantonale, CH-6929 Gravesano, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology, Clinica Ars Medica | Gravesano | 6929 | Switzerland |
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| ID | Title | Description |
|---|---|---|
| FG000 | 30 mg Paracetamol 3% (1 mL) | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2017 |
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Eligible patients will be randomised into four treatment groups (15 patients/group) to receive either one of the three single doses of Paracetamol 3% (30 mg, 60 mg, 90 mg) or placebo solution (1 mL, 2 mL, 3 mL) according to the randomised, parallel-group design.
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The study will be double-blind. Neither the Investigator/co-investigators/study nurses involved in the clinical study procedures, nor will the patients be aware of the administered treatment. At the site, syringes for injection will then be prepared by a person not involved in any other study-related activities where a bias is possible.
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| 60 mg Paracetamol 3% (2 mL) | Drug | Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. |
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| 90 mg Paracetamol 3% (3 mL) | Drug | Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. |
|
| Placebo, 0.9% saline solution | Drug | Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. |
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| NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection | Drug | Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
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| Up to 24 hours after injection |
| Time to First Postoperative Analgesia (Level 1 or 2) | Postoperatively, patients will be administered an analgesic as needed. Post-operative analgesia could include Ketorolac i.v. [Toradol] 30 mg (level 1 analgesia) and/or Tramadol i.v. 1 mg/kg (level 2 analgesia). The administered analgesic (level 1 or 2), analgesic dose and intake frequency will be decided according to the reported surgery-related pain intensity. Post-operatively, patients were administered an analgesic, as needed. Post-operative analgesia could include Ketorolac i.v. [Toradol] 30 mg (level 1 analgesia) and/or Tramadol i.v. 1 mg/kg (level 2 analgesia). | Up to 24 hours after surgery |
| Partecipants to Received Level 1 Analgesia | Partecipants to received Ketorolac i.v. [Toradol] 30 mg administration (level 1 analgesia) | from surgery day to 24 hours after surgery |
| Partecipants Received Level 2 Analgesia | Partecipants received Tramadol i.v. 1 mg/kg administration (level 2 analgesia) | from surgery day to 24 hours after surgery |
| Total Number of Partecipants Receiving Analgesic 1 | Total number of partecipants receiving Ketorolac i.v. [Toradol] 30 mg | From surgery day to 24 hours after surgery |
| Total Number of Partecipants Receiving Analgesic 2 | Total Number of Partecipants Receiving Tramadol i.v. 1 mg/kg | from surgery day to 24 hours after surgery |
| Percentage of Patients Requiring Analgesia in the First 2 h After Surgery End | Percentage of patients requiring analgesia (level 1 or level 2) in the first 2 h after surgery end | Form surgery day to 2 hours after surgery end |
| Percentage of Patients Requiring Analgesia in the First 4 h After Surgery End | Percentage of patients requiring analgesia (level 1 or level 2) in the first 4 h after surgery end | from surgery day to 4 hours after surgery end |
| Percentage of Patients Requiring Analgesia From Surgery End Until Eligibility for Discharge | Percentage of patients requiring analgesia (level 1 or level 2) from surgery end until eligibility for home discharge | from surgery day to 24 hours after surgery |
| Percentage of Patients Requiring Level 1 Analgesia From Surgery End Until Eligibility for Discharge | Percentage of patients requiring level 1 analgesia from surgery end until eligibility for home discharge | from surgery day to 24 hours after surgery |
| Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Discharge | Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Home Discharge | from surgery day to 24 hours after surgery |
| Percentage of Patients Requiring Supplementary Analgesia, Other Than the Planned Level 1 or 2 Analgesia | Percentage of patients requiring supplementary analgesia, other than the planned level 1 or 2 analgesia | from surgery day to 24 hours after surgery |
| Percentage of Patients Requiring Rescue Anaesthesia | Percentage of patients requiring rescue anaesthesia | from surgery day to 1 hour after injection |
| Time to Onset of Spinal Block (i.e. Time to Readiness for Surgery) | Spinal block/Readiness for surgery is defined as the presence of an adequate motor block (Bromage's score ≥ 2) and loss of Pinprick sensation, according to the Investigator's opinion. Time to readiness for surgery is defined as the time from the spinal injection (time 0 h) to achievement of readiness for surgery. | Up to 20 minutes after injection |
| Maximum Sensory Block | Maximum level of sensory block | Intraoperative |
| Time to Sensory Block | Time to maximum level of sensory block (bilateral Pinprick test using a 20-G hypodermic needle) | Intraoperative |
| Time to Regression of Spinal Block | Time period from spinal injection to the complete regression of sensory block to S1. | Up to 4 hours after injection |
| Time to Ambulation | Time to unassisted ambulation | Up to 24 hours after injection |
| Time to First Urine | Time to first spontaneous urine voiding | Up to 24 hours after injection |
| Time to Eligibility for Discharge | Time to eligibility for home discharge | Up to 24 hours after injection |
| FG001 | 60 mg Paracetamol 3% (2 mL) | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| FG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| FG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 30 mg Paracetamol 3% (1 mL) | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| BG001 | 60 mg Paracetamol 3% (2 mL) | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| BG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| BG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | Pain Intensity at Rest Evaluated Using a 0-100 mm VAS | The study primary efficacy measures will be the VAS scores at each predefined time-point after the anaesthetic intrathecal injection until eligibility for home discharge ( VAS scale is 0-100 mm, where 0 is no pain and 100 is maximum pain) | Posted | Mean | Standard Deviation | score on a scale | Pain intensity at rest evaluated using a 0-100 mm VAS at baseline (within 30 min before NIMP IT injection, 0 h), 1, 1.25, 1.5, 1.75, 2 h after NIMP IT injection, then every 30 min after NIMP IT injection until eligibility for home discharge. |
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| Secondary | Pain at Rest AUCt1-t2 | AUC t1-t2 is defined as the area under the pain intensity curve at the specified time-intervals | Posted | Mean | Standard Deviation | score on a scale*h | Up to 4 hours after injection |
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| Secondary | Pain at Rest AUClast | AUClast is defined as the area under the pain intensity curve from 0 h up to the last assessment time | Posted | Mean | Standard Deviation | score on a scale*h | Up to 24 hours after injection |
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| Secondary | Time to First Postoperative Analgesia (Level 1 or 2) | Postoperatively, patients will be administered an analgesic as needed. Post-operative analgesia could include Ketorolac i.v. [Toradol] 30 mg (level 1 analgesia) and/or Tramadol i.v. 1 mg/kg (level 2 analgesia). The administered analgesic (level 1 or 2), analgesic dose and intake frequency will be decided according to the reported surgery-related pain intensity. Post-operatively, patients were administered an analgesic, as needed. Post-operative analgesia could include Ketorolac i.v. [Toradol] 30 mg (level 1 analgesia) and/or Tramadol i.v. 1 mg/kg (level 2 analgesia). | Nine (9) patients in D1, 10 in D2, 8 in D3 and 14 in P treatment group did not require postoperative analgesia and were censored in the time to first post-operative analgesia analysis | Posted | Count of Participants | Participants | Up to 24 hours after surgery |
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| Secondary | Partecipants to Received Level 1 Analgesia | Partecipants to received Ketorolac i.v. [Toradol] 30 mg administration (level 1 analgesia) | Posted | Count of Participants | Participants | from surgery day to 24 hours after surgery |
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| Secondary | Partecipants Received Level 2 Analgesia | Partecipants received Tramadol i.v. 1 mg/kg administration (level 2 analgesia) | Posted | Count of Participants | Participants | from surgery day to 24 hours after surgery |
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| Secondary | Total Number of Partecipants Receiving Analgesic 1 | Total number of partecipants receiving Ketorolac i.v. [Toradol] 30 mg | Posted | Count of Participants | Participants | From surgery day to 24 hours after surgery |
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| Secondary | Total Number of Partecipants Receiving Analgesic 2 | Total Number of Partecipants Receiving Tramadol i.v. 1 mg/kg | Posted | Count of Participants | Participants | from surgery day to 24 hours after surgery |
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| Secondary | Percentage of Patients Requiring Analgesia in the First 2 h After Surgery End | Percentage of patients requiring analgesia (level 1 or level 2) in the first 2 h after surgery end | Posted | Count of Participants | Participants | Form surgery day to 2 hours after surgery end |
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| Secondary | Percentage of Patients Requiring Analgesia in the First 4 h After Surgery End | Percentage of patients requiring analgesia (level 1 or level 2) in the first 4 h after surgery end | Posted | Count of Participants | Participants | from surgery day to 4 hours after surgery end |
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| Secondary | Percentage of Patients Requiring Analgesia From Surgery End Until Eligibility for Discharge | Percentage of patients requiring analgesia (level 1 or level 2) from surgery end until eligibility for home discharge | Posted | Count of Participants | Participants | from surgery day to 24 hours after surgery |
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| Secondary | Percentage of Patients Requiring Level 1 Analgesia From Surgery End Until Eligibility for Discharge | Percentage of patients requiring level 1 analgesia from surgery end until eligibility for home discharge | Posted | Count of Participants | Participants | from surgery day to 24 hours after surgery |
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| Secondary | Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Discharge | Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Home Discharge | Posted | Count of Participants | Participants | from surgery day to 24 hours after surgery |
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| Secondary | Percentage of Patients Requiring Supplementary Analgesia, Other Than the Planned Level 1 or 2 Analgesia | Percentage of patients requiring supplementary analgesia, other than the planned level 1 or 2 analgesia | Posted | Number | participants | from surgery day to 24 hours after surgery |
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| Secondary | Percentage of Patients Requiring Rescue Anaesthesia | Percentage of patients requiring rescue anaesthesia | Posted | Count of Participants | Participants | from surgery day to 1 hour after injection |
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| Secondary | Time to Onset of Spinal Block (i.e. Time to Readiness for Surgery) | Spinal block/Readiness for surgery is defined as the presence of an adequate motor block (Bromage's score ≥ 2) and loss of Pinprick sensation, according to the Investigator's opinion. Time to readiness for surgery is defined as the time from the spinal injection (time 0 h) to achievement of readiness for surgery. | Posted | Median | Inter-Quartile Range | minutes | Up to 20 minutes after injection |
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| Secondary | Maximum Sensory Block | Maximum level of sensory block | Posted | Count of Participants | Participants | Intraoperative |
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| Secondary | Time to Sensory Block | Time to maximum level of sensory block (bilateral Pinprick test using a 20-G hypodermic needle) | Posted | Median | 95% Confidence Interval | minutes | Intraoperative |
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| Secondary | Time to Regression of Spinal Block | Time period from spinal injection to the complete regression of sensory block to S1. | Posted | Median | 95% Confidence Interval | minutes | Up to 4 hours after injection |
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| Secondary | Time to Ambulation | Time to unassisted ambulation | Posted | Median | 95% Confidence Interval | minutes | Up to 24 hours after injection |
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| Secondary | Time to First Urine | Time to first spontaneous urine voiding | Posted | Median | 95% Confidence Interval | minutes | Up to 24 hours after injection |
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| Secondary | Time to Eligibility for Discharge | Time to eligibility for home discharge | Posted | Median | 95% Confidence Interval | minutes | Up to 24 hours after injection |
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| Other Pre-specified | Number of Participants With Neurological Complications Including TNS | Number of Participants with Neurological Complications Including TNS at 24 h post-dose and at day 7±1 | Posted | Count of Participants | Participants | From anaesthetic intrathecal injection up to day 7±1 (i.e. 6±1 days after analgesic/anaesthetic IT injection and surgery) |
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Adverse events throughout the study 48 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 30 mg Paracetamol 3% (1 mL) | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 0 | 15 | 0 | 15 | 3 | 15 |
| EG001 | 60 mg Paracetamol 3% (2 mL) | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 0 | 15 | 0 | 15 | 4 | 15 |
| EG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 0 | 15 | 0 | 15 | 3 | 15 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| hypotension | Vascular disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| bradycardia | Cardiac disorders | MedDRA version 22.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Elisabetta Donati, Corporate Director Scientific Affairs | Sintetica SA | +41.91.640.42.50 | edonati@sintetica.com |
| May 4, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000077330 | Saline Solution |
| D012996 | Solutions |
| D007267 | Injections |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 hour after NIMP |
|
| 1.25 hour after NIMP |
|
| 1.50 hour after NIMP |
|
| 1.75 hour after NIMP |
|
| 2 hours after NIMP |
|
| 2.5 hours after NIMP |
|
| 3 hours after NIMP |
|
| 3.5 hours after NIMP |
|
| 4 hours after NIMP |
|
| 4.5 hours after NIMP |
|
| before discharge |
|
| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
|
|
| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
|
|
| OG001 | 60 mg Paracetamol 3% (2 mL) | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
|
|
60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT)
60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia.
The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.
NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min.
| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
|
|
| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
|
|
| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
|
|
| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
|
|
60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT)
60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia.
The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.
NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min.
| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
|
|
60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT)
60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia.
The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.
NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min.
| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
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60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
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60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
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60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
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60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
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| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
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| OG001 | 60 mg Paracetamol 3% (2 mL) | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
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| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
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| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
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| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
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| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
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| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
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| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
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60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG002 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| OG003 | Placebo, 0.9% Saline Solution | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
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