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

CHL.3/01-2016

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.

2016-10-01

2021-06-01

2021-06-01

Terminated

Early phase I

16

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.

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2023-11-21