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Optimal Site of Administration for Continuous Wound Infusion After Cesarean Section

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ClinicalTrials.gov Identifier: NCT01160913
Recruitment Status : Completed
First Posted : July 13, 2010
Last Update Posted : July 13, 2010
Sponsor:
Information provided by:
Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation

Brief 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.

Condition or disease Intervention/treatment Phase
Cesarean Section Procedure: Continuous wound infusion Procedure: Continuous wound Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Continuous wound infusion above the fascia Procedure: Continuous wound infusion
Active Comparator: Continuous wound infusion below the fascia Procedure: Continuous wound



Primary Outcome Measures :
  1. Cumulative intravenous morphine consumption [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Postoperative pain intensity at rest and mobilization [ Time Frame: admission, 3,6,12,24,36,48h ]
  2. adverse effects (nausea, vomiting, itching, sedation)


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective Cesarean Section under spinal anesthesia over37 weeks' gestation

Exclusion Criteria:

  • allergy to NSAIDs
  • ASA III or higher
  • refusal to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01160913


Locations
France
Hôpital Cochin
Paris, France, 75014
Sponsors and Collaborators
Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation