Optimal Site of Administration for Continuous Wound Infusion After Cesarean Section

NCT ID: NCT01160913

Last Updated: 2010-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Continuous wound infusion above the fascia

Group Type ACTIVE_COMPARATOR

Continuous wound infusion

Intervention Type PROCEDURE

Continuous wound infusion below the fascia

Group Type ACTIVE_COMPARATOR

Continuous wound

Intervention Type PROCEDURE

Interventions

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Continuous wound infusion

Intervention Type PROCEDURE

Continuous wound

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* elective Cesarean Section under spinal anesthesia over37 weeks' gestation

Exclusion Criteria

* allergy to NSAIDs
* ASA III or higher
* refusal to participate
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation

OTHER

Sponsor Role lead

Locations

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Hôpital Cochin

Paris, , France

Site Status

Countries

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France

References

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Rackelboom T, Strat SL, Silvera S, Schmitz T, Bassot A, Goffinet F, Ozier Y, Beaussier M, Mignon A. Improving continuous wound infusion effectiveness for postoperative analgesia after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2010 Oct;116(4):893-900. doi: 10.1097/AOG.0b013e3181f38ac6.

Reference Type DERIVED
PMID: 20859153 (View on PubMed)

Other Identifiers

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KTCESAR

Identifier Type: -

Identifier Source: org_study_id

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