Evaluating the efficacy on pain after a cesarean delivery of a local anesthetic (ropivacaïne) by comparing it with a placebo (NaCl).

Phase 1

• Conditions: Poor postoperative pain control leads to decreased satisfaction with care, prolonged recovery time and increased use of health care resources. Despite their efficacy, opioids are associated with nausea, vomiting, pruritus, drowsiness, and the risk for respiratory depression. As an alternatif, continuous wound infusion using a multi-orifice catheter with a local anesthetic has been suggested for pain therapy, however conflicting results are found in randomized controlled trials.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-004797-33-BE
• Lead Sponsor: CHU Tivoli

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-04
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

Inclusion criteria will be all patients undergoing cesarean delivery with
- a gestation of 34 weeks or more
- American Society of Anesthesiology (ASA) I or II
- = age 18 years
- signed informed consent
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 68
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria will be
- allergies to used analgesics
- ASA III or higher
- pre- or eclampsia
- diabetes mellitus type I or II
- postpartum hemorrhage (defined as = 1 L blood loss)
- BMI = 35
- preoperative opioid consumption/abuse
- psychiatric disorders
- patient refusal to participate
- language barrier

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 the trial is to evaluate the efficacy of continuous ropivacaine wound infusion through a multi-orifice catheter after cesarean delivery by comparing it with a continuous placebo wound infusion.<br>;Secondary Objective: The secondary objective is to evaluate the effect of continuous ropivacaine wound infusion through a multi-orifice catheter after cesarean delivery on pain intensity, on the incidence of opioids related adverse effects (post-operative nausea and vomiting, pruritus) and the time of first ambulation.;Primary end point(s): The primary outcome will be the total amount of opioid use, measured on the PCA device, in the first 48 hours after cesarean delivery.;Timepoint(s) of evaluation of this end point: Timepoint 0 hours: start of cesarean section defined as time of skin incision.<br>Timepoint 48 hours: period of 48 hours after surgery in which opioids use by PCA will be recorded.