Chloroprocaine 3% - Epidural Anesthesia in Unplanned Caesarean Section

Comparison of Epidural Chloroprocaine 3% and Ropivacaine 0.75% for Unplanned Caesarean Section in Labouring Women Who Have an Epidural Catheter in Situ

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.

Study Overview

• Status: Terminated
• Conditions: Unplanned Caesarean Section
• Intervention / Treatment: Drug: Chloroprocaine; Drug: Ropivacaine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven, Campus Gasthuisberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Informed consent: Signed written informed consent before inclusion in the study (obtained from women fulfilling the criteria, only when effective analgesia has been established)
2. Sex, pregnancy status and age: Labouring women with singleton pregnancy, ≥ 18 years old
3. Epidural catheter: Previously sited epidural catheter
4. ASA physical status: I-II
5. Analgesia: Effective analgesia established following combined spinal epidural analgesia (CSE)
6. Term gestation: ≥ 36 weeks
7. Caesarean section: Unplanned Caesarean section category 2 or 3, according to Lucas Classification
8. Body Mass Index (BMI): ≤ 40 kg/m2
9. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study.

Exclusion Criteria:

1. Physical findings: Clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to epidural anaesthesia
2. ASA physical status: III-V
3. Further anaesthesia: Patients expected to require further anaesthesia
4. Epidural catheter: Epidural catheter failure (epidural catheter replacement required or inability to provide effective analgesia)
5. Pregnancy: Labouring women with multiple pregnancy
6. Caesarean section: Elective Caesarean section
7. Allergy: ascertained or presumptive hypersensitivity to the active principle and /or formulations ingredients; ascertained or presumptive hypersensitivity to the amide and ester-type anaesthetics
8. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; ascertained psychiatric diseases, eclampsia, antepartum haemorrhage, sepsis, blood coagulation disorders, insulin dependent diabetes mellitus, terminal kidney failure
9. Medications: Medication known to interfere with the extent of regional blocks (see chloroprocaine and ropivacaine SmPCs) for 2 weeks before the start of the study
10. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study, calculated from the first day of the month following the last visit of the previous study
11. Drug, alcohol: history of drug or alcohol abuse
12. Plasma cholinesterase: Known plasma cholinesterase deficiency.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: Ampres
Active Comparator: 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.	Drug: 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.; Other Names: Naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oximetry	Maternal pulse oximetry (SpO2)	Up to 12 hours after surgery
Electrocardiogram	Maternal electrocardiogram	Up to 12 hours after surgery
Neonate Apgar	Neonate Apgar scores at 1 and 5 minutes	1 and 5 minutes after birth
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	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
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
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

Collaborators and Investigators

• Sponsor: Sintetica SA
• Collaborators: Cross Research S.A.
• Investigators: Principal Investigator: Marc Van de Velde, MD, Department of Anesthesiology, UZ Leuven, campus Gasthuisberg

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: September 27, 2016
• First Posted (Estimated): September 29, 2016

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine; Chloroprocaine
• Other Study ID Numbers: CHL.3/01-2016