Optimal Site of Administration for Continuous Wound Infusion After Cesarean Section
July 12, 2010 updated by: Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation
Evaluation of Optimal Anatomical Layer for Continuous Wound Infusion of Local Anesthetics Combined With NSAIDs Through a Multiorifice Catheter for Postoperative Pain Intensity After Elective Cesarean Delivery
The purpose of this randomized double-blind study is to evaluate in which anatomical layer (AF versus BF) continuous wound infusion of local anesthetics combined with NSAIDs through a multiorifice catheter has the best effectiveness during the first 48 hours on postoperative pain intensity after elective cesarean delivery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France, 75014
- Hôpital Cochin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- elective Cesarean Section under spinal anesthesia over37 weeks' gestation
Exclusion Criteria:
- allergy to NSAIDs
- ASA III or higher
- refusal to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Continuous wound infusion above the fascia
|
|
|
Active Comparator: Continuous wound infusion below the fascia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cumulative intravenous morphine consumption
Time Frame: 48 hours
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Postoperative pain intensity at rest and mobilization
Time Frame: admission, 3,6,12,24,36,48h
|
admission, 3,6,12,24,36,48h
|
|
adverse effects (nausea, vomiting, itching, sedation)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
July 12, 2010
First Submitted That Met QC Criteria
July 12, 2010
First Posted (Estimate)
July 13, 2010
Study Record Updates
Last Update Posted (Estimate)
July 13, 2010
Last Update Submitted That Met QC Criteria
July 12, 2010
Last Verified
September 1, 2007
More Information
Terms related to this study
Other Study ID Numbers
- KTCESAR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.