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Completed

NCT Number: NCT01160913

Optimal Site of Administration for Continuous Wound Infusion After Cesarean Section

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.

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Key information

Conditions

Cesarean Section

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Cochin

Paris, 75014, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective Cesarean Section under spinal anesthesia over37 weeks' gestation

Exclusion criteria

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

Treatment and study plan

Continuous wound infusion

Procedure

Continuous wound

Procedure

Primary outcomes

  1. Cumulative intravenous morphine consumption

    Time frame: 48 hours

Secondary outcomes

  1. Postoperative pain intensity at rest and mobilization

    Time frame: admission, 3,6,12,24,36,48h

  2. adverse effects (nausea, vomiting, itching, sedation)

Sponsors and collaborators

Lead sponsor

Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 13, 2010
Registry last updated
Jul 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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