Post-cesarean Pain Control Via Continuous Infusion of Ropivacain et Diclogenac Into the Wound Versus Intathecal Morphine

Phase 4

Withdrawn

• Conditions: Cesarean Section
• Interventions: Drug: Experimental; Drug: Reference

• Registration Number: NCT01211431
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The goal is to compare the quality of post-cesarean analgesia, the side effects and the incidence of residual scar pain obtained with intrathecal morphine (reference treatment) or with a continuous intra-wound solution including both ropivacain and diclofenac (experimental treatment).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-28
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-29
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• single, normally progressing pregancy
• term > 36 weeks amenorrhea
• BMI between 20 and 25 kg/m^2 before pregnancy
• height between 55 and 90 kg
• cesarean section by Joel-Cohen or Pfannenstiel techniques
• patient has signed consent
• patient has social security coverage

Exclusion Criteria

• Multiple pregnancy
• pathological pregnancy: hypertension (>140/90 mmHg found during the pregnancy), pre-eclampsia, gestational diabetes
• term < 36 weeks amenorrhea
• non-pregnancy related maternal pathology (insufficiency)
• obesity (BMI > 25 kg/m^2 before pregnancy)
• height < 155 cm or > 180 cm
• weight < 55 kg or > 90 kg
• patient refuses to sign consent
• surgical technique other than Joel-Cohen or Pfannenstiel
• hepatic insufficiency (prothrombin < 60%)
• contra-indications for rachianesthesia: infection, hemostasis problems (platelets < 80.109/L, prothrombin < 60%, TCA > 40s)
• allergy to local anesthestics
• patient is participating in another study, or has participated in another study within the last 6 months
• patient is under any type of guardianship

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Experimental	A solution including both ropivacain and diclofenac continuously delivered to the wound is used for post-cesarean pain control
Reference	Reference	Intrathécale morphine is used for post-cesarean pain control

Primary Outcome Measures

Name	Time	Method
Primary VAS score	36 hours post delivery	The patient is asked to evaluate cesarean-section related pain using a visual analog scale (VAS) score for pain on a scale of 1-10 in a sitting position.