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

NCT01211431 | Withdrawn Phase 4

• 2 other identifiers: AOI/2008/GA-012008-004643-11
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

cesarean section; pain; ropivacain; diclofena; morphine

Outcome Measures

Primary Outcomes (1)

• Primary VAS score

  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.

  36 hours post delivery

Study Arms (2)

Reference

ACTIVE COMPARATOR

Intrathécale morphine is used for post-cesarean pain control

Drug: Reference

Experimental

EXPERIMENTAL

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

Drug: Experimental

Interventions

Reference DRUG

Intrathécale morphine is used for post-cesarean pain control

Reference

Experimental DRUG

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

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoinie Guy Aya, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: September 29, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 25, 2015

Record last verified: 2015-03