Comparison of epidural Chloroprocaine 3% and Ropivacaine 0.75% forunplanned Caesarean section in labouring women who have an epiduralcatheter in situ

Phase 1

• Conditions: ocal epidural anaesthesia in labouring women who have an epiduralcatheter in situ and established analgesia and need unplannedCaesarean; MedDRA version: 20.0Level: PTClassification code 10024758Term: Local anaesthesiaSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2016-000298-20-DE
• Lead Sponsor: Sintetica S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-18
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 96

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 (4)
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 cooperate
with the investigator and to comply with the requirements of the entire study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 96
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to test the superiority in terms of the onset<br>time of anaesthesia and to evaluate the quality of epidural anaesthesia<br>and the safety of Chloroprocaine HCl 3% compared with Ropivacaine HCl<br>0.75% in patients with an epidural catheter in situ undergoing<br>unplanned Caesarean section.;Secondary Objective: Not Applicable;Primary end point(s): The primary study end-point is the time to the onset of anaesthesia (i.e.<br>the time to reach adequate surgical conditions);Timepoint(s) of evaluation of this end point: The time from T0 (start time of the epidural injection) to complete loss<br>of cold sensation to the metameric level T4 (block to T4), bilateral.