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

NCT ID: NCT01211431

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-10-31

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).

Conditions

Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reference

Intrathécale morphine is used for post-cesarean pain control

Group Type: ACTIVE_COMPARATOR

Reference

Intervention Type: DRUG

Intrathécale morphine is used for post-cesarean pain control

Experimental

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

Group Type: EXPERIMENTAL

Experimental

Intervention Type: DRUG

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

Interventions

Reference

Intrathécale morphine is used for post-cesarean pain control

Intervention Type: DRUG

Experimental

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

Intervention Type: DRUG

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%)
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoinie Guy Aya, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Other Identifiers

2008-004643-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AOI/2008/GA-01

Identifier Type: -

Identifier Source: org_study_id