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The doctors involved in the study did not enroll any patients
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| Name | Class |
|---|---|
| Cross Research S.A. | INDUSTRY |
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The study evaluate the quality of epidural anaesthesia and the safety of Chloroprocaine HCl 3% compared with Ropivacaine HCl 0.75% in patients with an epidural catheter in situ undergoing unplanned Caesarean section.
Labouring women who have an epidural catheter in situ and established analgesia, in need of an unplanned Caesarean section, will be randomly allocated to receive either Chloroprocaine HCl 3% (T-group) or Ropivacaine HCl 0.75% (R-group) epidurally. Prior to the epidural injection, the patient will be transferred to the operating theatre. The local anaesthetic solution will be freshly prepared and 20 mL will be administered by epidural injection, according to the standard hospital procedures, as detailed in the "Study Schedule" section below. Time T0 is defined as the start time of the first epidural injection of the investigational product. In case of pain or discomfort, a 6 mL epidural top-up of the same anaesthetic, i.e. Chloroprocaine HCl 3% in T-group and Ropivacaine HCl 0.75% in R-group, will be administered. The anaesthesiologist(s) administering the anaesthetic and collecting the data will be blinded with respect to the treatment given to each patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chloroprocaine | Experimental | Chloroprocaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. |
|
| Ropivacaine | Active Comparator | Ropivacaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chloroprocaine | Drug | The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the Onset of Anaesthesia | The time from T0 (start time of the epidural injection) to complete loss of cold sensation to the metameric level T4 (block to T4), bilateral. | Up to 1 hour after last epidural injection |
| Measure | Description | Time Frame |
|---|---|---|
| Time From T0 to Loss Light Touch Sensation | Time from T0 to loss light touch sensation to the metameric level T5 (block to T5), bilateral | Up to 1 hour after last epidural injection |
| Quality of the Block |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Van de Velde, MD | Department of Anesthesiology, UZ Leuven, campus Gasthuisberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven, campus Gasthuisberg | Leuven | 3000 | Belgium |
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Due to difficulties in enrolling patients, the enrolment stopped prematurely, and only 16 patients were screened and randomised (only at site N. 001).
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| ID | Title | Description |
|---|---|---|
| FG000 | Chloroprocaine | Chloroprocaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Chloroprocaine: The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered. |
| FG001 | Ropivacaine | Ropivacaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Ropivacaine: The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chloroprocaine | Chloroprocaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Chloroprocaine: The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 the Onset of Anaesthesia | The time from T0 (start time of the epidural injection) to complete loss of cold sensation to the metameric level T4 (block to T4), bilateral. | Posted | Mean | Standard Deviation | minutes | Up to 1 hour after last epidural injection |
|
Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1
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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 | Chloroprocaine | Chloroprocaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Chloroprocaine: The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotensio | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Guaita | Sintetica SA | +41 (0)91640 42 50 | aguaita@sintetica.com |
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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 | Aug 7, 2020 | Aug 3, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C004616 | chloroprocaine |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
|
| Ropivacaine | Drug | The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered. |
|
|
Quality of the block assessed between 10 and 20 min after the end of surgery by the anaesthesiologist and patient together using a 0-10 cm visual analogue scale (VAS; 10=excellent anaesthetic quality, 0=very poor anaesthetic quality)
| Quality of the block assessed between 10 and 20 minutes after the end of surgery |
| Maximum Metameric Level of the Sensory Block | Maximum metameric level of the sensory block assessed by three modalities (complete loss of cold, pinprick and light touch sensation) | Up to 1 hrs after last epidural injection |
| Motor Block Assessment | Motor block assessment (modified Bromage scale) at baseline, prior to incision and after surgery | Up to 12 hours after surgery |
| Proportion of Patients Who Need Top-up Anaesthesia | Proportion of patients who need top-up epidural anaesthesia (same anaesthetic as first epidural injection) | Up to 2 hours after last epidural injection |
| Proportion of Patients Who Need Supplementation of Opioids | Proportion of patients who need supplementation of the block intraoperatively with intravenous opioids | Up to 2 hours after last epidural injection |
| Proportion of Patients Who Need General Anaesthesia | Proportion of patients who need general anaesthesia | Up to 2 hours after last epidural injection |
| Discomfort and Pain During Surgery | Discomfort and pain assessed during surgery through spontaneous patient's reporting and questioning by the Investigator/anaesthesiologist | Up to 2 hours after last epidural injection |
| First Breakthrough Pain | First breakthrough pain assessed by the patient, recorded on a 0-10 cm VAS (0=no pain, 10= most severe pain imaginable) | Up to 12 hours after surgery |
| Maternal Treatment-emergent Adverse Events | Maternal treatment-emergent adverse events, with particular attention to pain (see above), pruritus, nausea, vomiting | Up to day 3±1 after surgery |
| Pulse Rate | Maternal pulse rate | Up to 12 hours after surgery |
| Oximetry | Maternal pulse oximetry (SpO2) | Up to 12 hours after surgery |
| Electrocardiogram | Maternal electrocardiogram | Up to 12 hours after surgery |
| Total Dose of Phenylephrine | Total dose (μg) of phenylephrine | Up to 2 hours after last epidural injection |
| Total Dose of Atropine | Total dose (mg) of atropine | Up to 2 hours after last epidural injection |
| Intravenous Fluids | Total volume (ml) of intravenous fluids | Up to 12 hours after surgery |
| Neonate Apgar | Neonate Apgar scores at 1 and 5 minutes | 1 and 5 minutes after birth |
| Foetal Hypoxic Stress | Indication of foetal hypoxic stress | Up to 12 hours after surgery |
| Pain at the Site of Surgery | Pain at the site of surgery at final visit/early termination visit, recorded on a 0-10 cm VAS (0=no pain, 10=most severe pain imaginable) | Up to 12 hours after surgery |
| Pain at the Site of Epidural Injection | Pain at the site of epidural injection at final visit/early termination visit, recorded on a 0-10 cm VAS (0=no pain, 10=severe pain) | Up to 12 hours after surgery |
| Concomitant Medications | Maternal concomitant medications | Up to day 3±1 after surgery |
| Neonatal Adverse Events | Neonatal adverse events | Up to day 3±1 after surgery |
| BG001 | Ropivacaine | Ropivacaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Ropivacaine: The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Ropivacaine | Ropivacaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Ropivacaine: The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered. |
|
|
| Secondary | Time From T0 to Loss Light Touch Sensation | Time from T0 to loss light touch sensation to the metameric level T5 (block to T5), bilateral | Posted | Mean | Standard Deviation | minutes | Up to 1 hour after last epidural injection |
|
|
|
| Secondary | Quality of the Block | Quality of the block assessed between 10 and 20 min after the end of surgery by the anaesthesiologist and patient together using a 0-10 cm visual analogue scale (VAS; 10=excellent anaesthetic quality, 0=very poor anaesthetic quality) | Posted | Mean | Standard Deviation | units on a scale | Quality of the block assessed between 10 and 20 minutes after the end of surgery |
|
|
|
| Secondary | Maximum Metameric Level of the Sensory Block | Maximum metameric level of the sensory block assessed by three modalities (complete loss of cold, pinprick and light touch sensation) | Not Posted | Up to 1 hrs after last epidural injection | Participants |
| Secondary | Motor Block Assessment | Motor block assessment (modified Bromage scale) at baseline, prior to incision and after surgery | Not Posted | Up to 12 hours after surgery | Participants |
| Secondary | Proportion of Patients Who Need Top-up Anaesthesia | Proportion of patients who need top-up epidural anaesthesia (same anaesthetic as first epidural injection) | Not Posted | Up to 2 hours after last epidural injection | Participants |
| Secondary | Proportion of Patients Who Need Supplementation of Opioids | Proportion of patients who need supplementation of the block intraoperatively with intravenous opioids | Not Posted | Up to 2 hours after last epidural injection | Participants |
| Secondary | Proportion of Patients Who Need General Anaesthesia | Proportion of patients who need general anaesthesia | Not Posted | Up to 2 hours after last epidural injection | Participants |
| Secondary | Discomfort and Pain During Surgery | Discomfort and pain assessed during surgery through spontaneous patient's reporting and questioning by the Investigator/anaesthesiologist | Not Posted | Up to 2 hours after last epidural injection | Participants |
| Secondary | First Breakthrough Pain | First breakthrough pain assessed by the patient, recorded on a 0-10 cm VAS (0=no pain, 10= most severe pain imaginable) | Not Posted | Up to 12 hours after surgery | Participants |
| Secondary | Maternal Treatment-emergent Adverse Events | Maternal treatment-emergent adverse events, with particular attention to pain (see above), pruritus, nausea, vomiting | Not Posted | Up to day 3±1 after surgery | Participants |
| Secondary | Pulse Rate | Maternal pulse rate | Not Posted | Up to 12 hours after surgery | Participants |
| Secondary | Oximetry | Maternal pulse oximetry (SpO2) | Not Posted | Up to 12 hours after surgery | Participants |
| Secondary | Electrocardiogram | Maternal electrocardiogram | Not Posted | Up to 12 hours after surgery | Participants |
| Secondary | Total Dose of Phenylephrine | Total dose (μg) of phenylephrine | Not Posted | Up to 2 hours after last epidural injection | Participants |
| Secondary | Total Dose of Atropine | Total dose (mg) of atropine | Not Posted | Up to 2 hours after last epidural injection | Participants |
| Secondary | Intravenous Fluids | Total volume (ml) of intravenous fluids | Not Posted | Up to 12 hours after surgery | Participants |
| Secondary | Neonate Apgar | Neonate Apgar scores at 1 and 5 minutes | Not Posted | 1 and 5 minutes after birth | Participants |
| Secondary | Foetal Hypoxic Stress | Indication of foetal hypoxic stress | Not Posted | Up to 12 hours after surgery | Participants |
| Secondary | Pain at the Site of Surgery | Pain at the site of surgery at final visit/early termination visit, recorded on a 0-10 cm VAS (0=no pain, 10=most severe pain imaginable) | Not Posted | Up to 12 hours after surgery | Participants |
| Secondary | Pain at the Site of Epidural Injection | Pain at the site of epidural injection at final visit/early termination visit, recorded on a 0-10 cm VAS (0=no pain, 10=severe pain) | Not Posted | Up to 12 hours after surgery | Participants |
| Secondary | Concomitant Medications | Maternal concomitant medications | Not Posted | Up to day 3±1 after surgery | Participants |
| Secondary | Neonatal Adverse Events | Neonatal adverse events | Not Posted | Up to day 3±1 after surgery | Participants |
| 0 |
| 8 |
| 0 |
| 8 |
| 5 |
| 8 |
| EG001 | Ropivacaine | Ropivacaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Ropivacaine: The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered. | 0 | 8 | 0 | 8 | 8 | 8 |
| post lumbar puncture syndrom | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| POst procedural disconfort | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| procedural nausea | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| procedural pain | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| dysphagia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| anemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| skin lesion | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
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| D000588 |
| Amines |