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Optimal Site of Administration for Continuous Wound Infusion After Cesarean Section

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01160913
First Posted: July 13, 2010
Last Update Posted: July 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation
  Purpose
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 Intervention Phase
Cesarean Section Procedure: Continuous wound infusion Procedure: Continuous wound Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation:

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

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

Enrollment: 56
Study Start Date: October 2007
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Continuous wound infusion above the fascia Procedure: Continuous wound infusion
Active Comparator: Continuous wound infusion below the fascia Procedure: Continuous wound

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01160913     History of Changes
Other Study ID Numbers: KTCESAR
First Submitted: July 12, 2010
First Posted: July 13, 2010
Last Update Posted: July 13, 2010
Last Verified: September 2007


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