Post-cesarean Pain Control Via Continuous Infusion of Ropivacain et Diclogenac Into the Wound Versus Intathecal Morphine: Comparison of the Quality of Analgesia, Side Effects, and the Incidence of Residual Scar Pain

Centre Hospitalier Universitaire de Nīmes0 sitesSeptember 2010

ConditionsCesarean Section

InterventionsReference Experimental

DrugsReference Experimental

Overview

Phase: Phase 4
Intervention: Reference
Conditions: Cesarean Section
Sponsor: Centre Hospitalier Universitaire de Nīmes
Primary Endpoint: Primary VAS score
Status: Withdrawn
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

October 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

Eligibility Criteria

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%)

Arms & Interventions

Reference

Intrathécale morphine is used for post-cesarean pain control

Intervention: Reference

Experimental

A solution including both ropivacain and diclofenac continuously delivered to the wound is used for post-cesarean pain control

Intervention: Experimental

Outcomes

Primary Outcomes

Primary VAS score

Time Frame: 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.