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NCT01160913 Clinical Trial

Optimal Site of Administration for Continuous Wound Infusion After Cesarean Section

Cesarean Section Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01160913
Other study ID # KTCESAR
Secondary ID
Status Completed
Phase Phase 3
First received July 12, 2010
Last updated July 12, 2010
Start date October 2007
Est. completion date December 2008

Study information
Verified date September 2007
Source Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date December 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- elective Cesarean Section under spinal anesthesia over37 weeks' gestation

Exclusion Criteria:

- allergy to NSAIDs

- ASA III or higher

- refusal to participate

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Continuous wound infusion

• Continuous wound

Locations
Country Name City State
France Hôpital Cochin Paris

Sponsors (1)
Lead Sponsor Collaborator
Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cumulative intravenous morphine consumption 48 hours No
Secondary Postoperative pain intensity at rest and mobilization admission, 3,6,12,24,36,48h No
Secondary adverse effects (nausea, vomiting, itching, sedation) Yes
See also
  Status Clinical Trial Phase
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Active, not recruiting NCT04965779 - The Effect of Abdominal Binder Use on Postpartum Pain, Bleeding, and Breastfeeding Success in Cesarean Delivery Women N/A
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Completed NCT00987701 - Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors N/A
Completed NCT00991627 - Different Approaches to Maternal Hypotension During Cesarean Section Phase 4
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Terminated NCT00524511 - Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples N/A
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Completed NCT00517140 - Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function N/A
Terminated NCT05051150 - Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Caesarean Section Phase 4
Terminated NCT03695172 - Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section Phase 4
Recruiting NCT06247852 - Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
Completed NCT06012747 - Pain After Cesarean Section - A Danish Multicenter Cohort Study.
Not yet recruiting NCT05187520 - Naldebain for Control of Post-Cesarean Section Pain Phase 2
Not yet recruiting NCT04999670 - Fascial Closure and Post-caesarean Pain N/A