Chloroprocaine 3% - Epidural Anesthesia in Unplanned Caesarean Section

NCT ID: NCT02919072

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2021-06-30

Brief Summary

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.

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.

Conditions

Unplanned Caesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Chloroprocaine

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Ampres; Naropin

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cross Research S.A.

INDUSTRY

Sponsor Role: collaborator

Sintetica SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Van de Velde, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, UZ Leuven, campus Gasthuisberg

Locations

UZ Leuven, campus Gasthuisberg

Leuven, , Belgium

Countries

Belgium

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CHL.3/01-2016

Identifier Type: -

Identifier Source: org_study_id