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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003778-17 | EudraCT Number |
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| Name | Class |
|---|---|
| Cross S.A. | INDUSTRY |
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This study evaluate the effect of 3 doses of Chloroprocaine HCl 1% (30, 40 and 50 mg) for spinal anaesthesia in adult patients undergoing short duration elective surgery of the lower limb. Patients undergoing elective short-duration lower limb surgery will be randomised into 3 treatment groups (15 patients per group) to receive one of the 3 single doses of Chloroprocaine HCl 1%, i.e. either D1, D2 or D3, via intrathecal injection.
To evaluate the efficacy of the three Chloroprocaine HCl 1% doses (i.e. D1, D2 and D3) in terms of time to complete regression of spinal block (i.e. end of anaesthesia)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 mL Chloroprocaine HCl 1% | Experimental | Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl) |
|
| 4 mL Chloroprocaine HCl 1% | Experimental | Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl) |
|
| 5 mL Chloroprocaine HCl 1% | Experimental | Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chloroprocaine HCl 1% | Drug | Intrathecal Route |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Regression of Spinal Block | When Bromage score returns to 0 and sensitive perception returns to S1 To evaluate the efficacy of the three Chloroprocaine HCI 1% doses (i.e. 30 mg, 40 mg e 50 mg) in terms of time to complete regression of spinal block (i.e. end of anaesthesia) Bromage Score is comprised between 1 and 4 (1 equals Free movement of legs and feet while 4 stands for Unable to move legs or feet) | Up to 5 hours after regression of two dermatomers |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Onset of Sensory Block (Corresponding to Readiness for Surgery) | Time period from spinal injection (time 0 h) to achievement of sensory block The evolution of both sensory and motor blocks, including sensory block metameric level, will be evaluated every 2 min until readiness for surgery, every 5 min until the maximum level is reached (two consecutive observations with the same level of sensory block) and then every 5 min until regression of two dermatomers with respect to the maximum level of sensory block. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefano MD Bonarelli | Istituto Ortopedico Rizzoli, SC Anestesia e Terapia Intensiva post-operatoria e del dolore IOR-IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stefano Bonarelli | Bologna | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33610175 | Derived | Ghisi D, Boschetto G, Spinelli AM, Giannone S, Frugiuele J, Ciccarello M, Bonarelli S. Spinal anaesthesia with Chloroprocaine HCl 1% for elective lower limb procedures of short duration: a prospective, randomised, observer-blind study in adult patients. BMC Anesthesiol. 2021 Feb 20;21(1):58. doi: 10.1186/s12871-021-01279-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3 mL Chloroprocaine HCl 1% | Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl) Chloroprocaine HCl 1%: Intrathecal Route |
| FG001 | 4 mL Chloroprocaine HCl 1% | Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl) Chloroprocaine HCl 1%: Intrathecal Route |
| FG002 | 5 mL Chloroprocaine HCl 1% | Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl) Chloroprocaine HCl 1%: Intrathecal Route |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3 mL Chloroprocaine HCl 1% | Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl) Chloroprocaine HCl 1%: Intrathecal Route |
| BG001 | 4 mL Chloroprocaine HCl 1% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Regression of Spinal Block | When Bromage score returns to 0 and sensitive perception returns to S1 To evaluate the efficacy of the three Chloroprocaine HCI 1% doses (i.e. 30 mg, 40 mg e 50 mg) in terms of time to complete regression of spinal block (i.e. end of anaesthesia) Bromage Score is comprised between 1 and 4 (1 equals Free movement of legs and feet while 4 stands for Unable to move legs or feet) | Posted | Mean | Standard Deviation | minutes | Up to 5 hours after regression of two dermatomers |
|
7 days
No SAEs and No subject discontinued for AEs
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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 | 3 mL Chloroprocaine HCl 1% | Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl) Chloroprocaine HCl 1%: Intrathecal Route |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment | The most frequent AE was procedural pain (verbatim: pain at the site of surgery) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elisabetta Donati Clinical Project Leader | Sintetica SA, via Penate 5 Mendrisio | +41.91.640.42.50 | edonati@sintetica.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 3, 2014 | Apr 26, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 2, 2016 | Apr 26, 2021 | SAP_001.pdf |
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| Up to 40 min after spinal injection |
| Time to Onset of Motor Block | Time period from spinal injection (time 0 h) to achievement of motor block | Up to 40 min after spinal injection |
| Time to Readiness for Surgery | Time period from completion of spinal injection (time 0 h) to achievement of sensory and motor block adequate for surgery, i.e. loss of Pinprick sensation and Bromage's score ≥ 2 at the required metameric level ≥ T12 | Up to 40 min after spinal injection |
| Time to Regression of Spinal Block | Up to 1 h and 40 min after readiness for surgery |
| Time to Resolution of Sensory Block to S1(Min) | Time period from spinal injection (time 0 h) to the time when sensitive perception has returned to S1 | Up to 5 h after regression of two dermatomers |
| Time to Resolution of Motor Block | Time period from spinal injection (time 0 h) to the time when the Bromage score has returned to 0 (Bromage Scale comprises from 1 to 4, where 1 equals Free movement of legs and feet while 4 stands for Unable to move legs or feet) | Up to 5 h after regression of two dermatomers |
| Time to Unassisted Ambulation | Time period from spinal injection (time 0 h) to the time when the patient can walk unassisted | Up to 5 h after regression of two dermatomers |
| Sensory Block Metameric Level | Metameric level of sensory block assessed from spinal injection (time 0 h) until regression of sensory block to S1 | Up to 5 h after regression of two dermatomers |
| Maximum Level of Sensory Block | Maximum metameric level of sensory block (decreased or absent sensation) achieved | Up to 1 h and 40 min after readiness for surgery |
| Time to Maximum Level of Sensory Block | Time period from spinal injection (Tsp; time 0 h) to the time when the maximum metameric level of sensory block is achieved (consider the time of the first of the two consecutive observations with the same level of sensory block) | Up to 1 h and 40 min after readiness for surgery |
| Time to Regression of Two Dermatomers With Respect to the Maximum Level of Sensory Block | Time period from spinal injection (time 0 h) to the time when the sensory block decrease of two dermatomers with respect to the maximum level of sensory block | Up to 5 h after regression of two dermatomers |
| Time to Eligibility for Home Discharge | Time period from spinal injection (time 0 h) to the time when the criteria from discharge are met, even if according to the hospital procedures the patient is discharged at a later time | Expected up to 24 hrs post surgery |
| Time to First Spontaneous Urine Voiding | Time period from spinal injection ( time 0 h) to the first time when the patient can pass urine unassisted | Expected up to 24 hrs post surgery |
| Time to First Post-operative Analgesia | Time from spinal injection (time 0 h) to first post-operative analgesia | Expected up to 24 hrs post surgery |
| Time to Administration of Rescue Anaesthesia or Rescue Analgesia | Expected up to 24 hrs post surgery |
| Concentration of 2-chloro-4-aminobenzoic Acid (CABA) in Plasma | at pre-dose, 5, 10, 30 and 60 min after spinal puncture |
| Excretion of 2-chloro-4-aminobenzoic Acid (CABA) in Urine | Time period from spinal injection ( time 0 h) to the first time when the patient can pass urine unassisted | at the time of first urine voiding post surgery |
| Treatment-emergent Adverse Events (TEAEs) | All AEs occurring or worsening after the dose of IMP | Up to Day 6 +/- 1 after spinal puncture |
| Transient Neurological Symptoms (TNS) | Up to Day 6 +/- 1 after spinal puncture |
| Pain Assessment at the Site of Injection and at the Site of Surgery | Number of patients with pain at the site of injection and at the site of surgery | Up to Day 6 +/- 1 after spinal puncture |
| Heart Rate | The following normal ranges Heart Rate parameters will be used: 50-90 beats/min | Expected up to 24 hrs post surgery |
| Blood Pressure | The following normal ranges Systolic and Diastolic Blood Pressure parameters will be used: Systolic Blood Pressure: 100-139 mmHg Diastolic Blood Pressure: 50-89 mmHg | Expected up to 24 hrs post surgery |
| SpO2 | The following normal ranges SpO2 parameters will be used: Peripheral Oxygen Saturation: ≥ 95% | Expected up to 24 hrs post surgery |
Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)
Chloroprocaine HCl 1%: Intrathecal Route
| BG002 | 5 mL Chloroprocaine HCl 1% | Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl) Chloroprocaine HCl 1%: Intrathecal Route |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl) Chloroprocaine HCl 1%: Intrathecal Route |
| OG002 | 5 mL Chloroprocaine HCl 1% | Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl) Chloroprocaine HCl 1%: Intrathecal Route |
|
|
| Secondary | Time to Onset of Sensory Block (Corresponding to Readiness for Surgery) | Time period from spinal injection (time 0 h) to achievement of sensory block The evolution of both sensory and motor blocks, including sensory block metameric level, will be evaluated every 2 min until readiness for surgery, every 5 min until the maximum level is reached (two consecutive observations with the same level of sensory block) and then every 5 min until regression of two dermatomers with respect to the maximum level of sensory block. | Posted | Mean | Standard Deviation | minutes | Up to 40 min after spinal injection |
|
|
|
| Secondary | Time to Onset of Motor Block | Time period from spinal injection (time 0 h) to achievement of motor block | Posted | Mean | Standard Deviation | minutes | Up to 40 min after spinal injection |
|
|
|
| Secondary | Time to Readiness for Surgery | Time period from completion of spinal injection (time 0 h) to achievement of sensory and motor block adequate for surgery, i.e. loss of Pinprick sensation and Bromage's score ≥ 2 at the required metameric level ≥ T12 | Posted | Mean | Standard Deviation | minutes | Up to 40 min after spinal injection |
|
|
|
| Secondary | Time to Regression of Spinal Block | Posted | Mean | Standard Deviation | hours | Up to 1 h and 40 min after readiness for surgery |
|
|
|
| Secondary | Time to Resolution of Sensory Block to S1(Min) | Time period from spinal injection (time 0 h) to the time when sensitive perception has returned to S1 | Posted | Mean | Standard Deviation | hours | Up to 5 h after regression of two dermatomers |
|
|
|
| Secondary | Time to Resolution of Motor Block | Time period from spinal injection (time 0 h) to the time when the Bromage score has returned to 0 (Bromage Scale comprises from 1 to 4, where 1 equals Free movement of legs and feet while 4 stands for Unable to move legs or feet) | Posted | Mean | Standard Deviation | hours | Up to 5 h after regression of two dermatomers |
|
|
|
| Secondary | Time to Unassisted Ambulation | Time period from spinal injection (time 0 h) to the time when the patient can walk unassisted | Posted | Mean | Standard Deviation | hours | Up to 5 h after regression of two dermatomers |
|
|
|
| Secondary | Sensory Block Metameric Level | Metameric level of sensory block assessed from spinal injection (time 0 h) until regression of sensory block to S1 | Posted | Number | participants | Up to 5 h after regression of two dermatomers |
|
|
|
| Secondary | Maximum Level of Sensory Block | Maximum metameric level of sensory block (decreased or absent sensation) achieved | Posted | Number | participants | Up to 1 h and 40 min after readiness for surgery |
|
|
|
| Secondary | Time to Maximum Level of Sensory Block | Time period from spinal injection (Tsp; time 0 h) to the time when the maximum metameric level of sensory block is achieved (consider the time of the first of the two consecutive observations with the same level of sensory block) | Posted | Mean | Standard Deviation | minutes | Up to 1 h and 40 min after readiness for surgery |
|
|
|
| Secondary | Time to Regression of Two Dermatomers With Respect to the Maximum Level of Sensory Block | Time period from spinal injection (time 0 h) to the time when the sensory block decrease of two dermatomers with respect to the maximum level of sensory block | Posted | Mean | Standard Deviation | hours | Up to 5 h after regression of two dermatomers |
|
|
|
| Secondary | Time to Eligibility for Home Discharge | Time period from spinal injection (time 0 h) to the time when the criteria from discharge are met, even if according to the hospital procedures the patient is discharged at a later time | Posted | Mean | Standard Deviation | hours | Expected up to 24 hrs post surgery |
|
|
|
| Secondary | Time to First Spontaneous Urine Voiding | Time period from spinal injection ( time 0 h) to the first time when the patient can pass urine unassisted | Posted | Mean | Standard Deviation | hours | Expected up to 24 hrs post surgery |
|
|
|
| Secondary | Time to First Post-operative Analgesia | Time from spinal injection (time 0 h) to first post-operative analgesia | Posted | Mean | Standard Deviation | hours | Expected up to 24 hrs post surgery |
|
|
|
| Secondary | Time to Administration of Rescue Anaesthesia or Rescue Analgesia | Posted | Mean | Standard Deviation | hours | Expected up to 24 hrs post surgery |
|
|
|
| Secondary | Concentration of 2-chloro-4-aminobenzoic Acid (CABA) in Plasma | Posted | Mean | Standard Deviation | minutes | at pre-dose, 5, 10, 30 and 60 min after spinal puncture |
|
|
|
| Secondary | Excretion of 2-chloro-4-aminobenzoic Acid (CABA) in Urine | Time period from spinal injection ( time 0 h) to the first time when the patient can pass urine unassisted | Posted | Mean | Standard Deviation | ng/mL | at the time of first urine voiding post surgery |
|
|
|
| Secondary | Treatment-emergent Adverse Events (TEAEs) | All AEs occurring or worsening after the dose of IMP | Posted | Number | participants | Up to Day 6 +/- 1 after spinal puncture |
|
|
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| Secondary | Transient Neurological Symptoms (TNS) | Posted | Number | participants | Up to Day 6 +/- 1 after spinal puncture |
|
|
|
| Secondary | Pain Assessment at the Site of Injection and at the Site of Surgery | Number of patients with pain at the site of injection and at the site of surgery | Posted | Number | participants | Up to Day 6 +/- 1 after spinal puncture |
|
|
|
| Secondary | Heart Rate | The following normal ranges Heart Rate parameters will be used: 50-90 beats/min | Posted | Mean | Standard Deviation | beats/min | Expected up to 24 hrs post surgery |
|
|
|
| Secondary | Blood Pressure | The following normal ranges Systolic and Diastolic Blood Pressure parameters will be used: Systolic Blood Pressure: 100-139 mmHg Diastolic Blood Pressure: 50-89 mmHg | Posted | Mean | Standard Deviation | mmHg | Expected up to 24 hrs post surgery |
|
|
|
| Secondary | SpO2 | The following normal ranges SpO2 parameters will be used: Peripheral Oxygen Saturation: ≥ 95% | Posted | Mean | Standard Deviation | percentage | Expected up to 24 hrs post surgery |
|
|
|
| 0 |
| 15 |
| 15 |
| 15 |
| EG001 | 4 mL Chloroprocaine HCl 1% | Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl) Chloroprocaine HCl 1%: Intrathecal Route | 0 | 15 | 13 | 15 |
| EG002 | 5 mL Chloroprocaine HCl 1% | Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl) Chloroprocaine HCl 1%: Intrathecal Route | 0 | 15 | 13 | 15 |
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| injection site pain | General disorders | Systematic Assessment |
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| nausea | Gastrointestinal disorders | Systematic Assessment |
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| diarrhoae | Gastrointestinal disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
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| bradycardia | Cardiac disorders | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| T4 |
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| T6 |
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| T7 |
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| T8 |
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| T10 |
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| T12 |
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| L1 |
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| Title | Measurements |
|---|---|
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| T4 |
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| T6 |
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| T7 |
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| T8 |
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| T10 |
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| T12 |
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| L1 |
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| 30 minutes post-dose |
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| 60 minutes post-dose |
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| Title | Measurements |
|---|---|
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| nausea |
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| diarrhea |
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| vomiting |
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| bradycardia |
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| Title | Measurements |
|---|---|
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| day 2 |
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| day 7 |
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| discharge |
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| Systolic Blood Pressure discharge |
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| Diastolic Blood Pressure screening |
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| Diastolic Blood Pressure baseline |
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| Diastolic Blood Pressure discharge |
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| discharge |
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