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

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01211431

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section	Drug: Reference Drug: Experimental	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2010

Anticipated Primary Completion Date :

Oct 1, 2012

Anticipated Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Reference Intrathécale morphine is used for post-cesarean pain control	Drug: Reference Intrathécale morphine is used for post-cesarean pain control
Experimental: Experimental A solution including both ropivacain and diclofenac continuously delivered to the wound is used for post-cesarean pain control	Drug: Experimental A solution including both ropivacain and diclofenac continuously delivered to the wound is used for post-cesarean pain control

Arm

Intervention/Treatment

Active Comparator: Reference

Intrathécale morphine is used for post-cesarean pain control

Drug: Reference

Intrathécale morphine is used for post-cesarean pain control

Experimental: Experimental

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

Drug: Experimental

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

Principal Investigator: Antoinie Guy Aya, MD, Centre Hospitalier Universitaire de Nîmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov Identifier:

NCT01211431

Other Study ID Numbers:

AOI/2008/GA-01
2008-004643-11

First Posted:

Sep 29, 2010

Last Update Posted:

Mar 25, 2015

Last Verified:

Mar 1, 2015

Keywords provided by Centre Hospitalier Universitaire de Nīmes

Study Results

No Results Posted as of Mar 25, 2015