Optimal Site of Administration for Continuous Wound Infusion After Cesarean Section

Phase 3

Completed

• Conditions: Cesarean Section
• Interventions: Procedure: Continuous wound infusion; Procedure: Continuous wound

• Registration Number: NCT01160913
• Lead Sponsor: Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation

Brief Summary

The purpose of this randomized double-blind study is to evaluate in which anatomical layer (AF versus BF) continuous wound infusion of local anesthetics combined with NSAIDs through a multiorifice catheter has the best effectiveness during the first 48 hours on postoperative pain intensity after elective cesarean delivery.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-09
• Study Start: 2007-10
• Primary Completion: 2008-09
• Study Completion: 2008-12
• Study First Submitted: 2010-07-12
• Study First Submitted QC: 2010-07-12
• Last Update Submitted: 2010-07-12
• Study First Posted: 2010-07-13
• Last Update Posted: 2010-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

• elective Cesarean Section under spinal anesthesia over37 weeks' gestation

Exclusion Criteria

• allergy to NSAIDs
• ASA III or higher
• refusal to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous wound infusion above the fascia	Continuous wound infusion	-
Continuous wound infusion below the fascia	Continuous wound	-

Primary Outcome Measures

Name	Time	Method
Cumulative intravenous morphine consumption	48 hours

Secondary Outcome Measures

Name	Time	Method
Postoperative pain intensity at rest and mobilization	admission, 3,6,12,24,36,48h
adverse effects (nausea, vomiting, itching, sedation)

Trial Locations

Locations (1)

Hôpital Cochin; 🇫🇷 Paris, France