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

This study has been withdrawn prior to enrollment.

(No inclusions.)

Sponsor:

Information provided by (Responsible Party):

Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov Identifier:

NCT01211431

First received: September 28, 2010

Last updated: March 22, 2013

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 28, 2010

Last Updated Date

March 22, 2013

Start Date ^ICMJE

September 2010

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Primary VAS score [ Time Frame: 36 hours post delivery ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01211431 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cesarean Section

Intervention ^ICMJE

Drug: Reference
Intrathécale morphine 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

Study Arm (s)

Active Comparator: Reference
Intrathécale morphine is used for post-cesarean pain control

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

Intervention: Drug: Experimental

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Estimated Completion Date

October 2012

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01211431

Other Study ID Numbers ^ICMJE

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

Has Data Monitoring Committee

Responsible Party

Centre Hospitalier Universitaire de Nīmes

Study Sponsor ^ICMJE

Centre Hospitalier Universitaire de Nīmes

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Antoinie Guy Aya, MD

Centre Hospitalier Universitaire de Nîmes

Information Provided By

Centre Hospitalier Universitaire de Nīmes

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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