Chloroprocaine 3% - Epidural Anesthesia in Unplanned Caesarean Section

• Status: Terminated
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sintetica SA
• Collaborators: Aml Research; Cross Research S.A.
• Treatments: Anesthetics; Chloroprocaine; Pharmaceutical Solutions; Procaine; Ropivacaine

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.