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Optimal Site of Administration for Continuous Wound Infusion After Cesarean Section

This study has been completed.
Sponsor:
Information provided by:
Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation
ClinicalTrials.gov Identifier:
NCT01160913
First received: July 12, 2010
Last updated: NA
Last verified: September 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative pain intensity at rest and mobilization [ Time Frame: admission, 3,6,12,24,36,48h ] [ Designated as safety issue: No ]
  • adverse effects (nausea, vomiting, itching, sedation) [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01160913

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

No publications provided by Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT01160913     History of Changes
Other Study ID Numbers: KTCESAR
Study First Received: July 12, 2010
Last Updated: July 12, 2010
Health Authority: France: Ministry of Health

ClinicalTrials.gov processed this record on May 16, 2013