NCT01160913

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2010

Completed
Last Updated

July 13, 2010

Status Verified

September 1, 2007

Enrollment Period

11 months

First QC Date

July 12, 2010

Last Update Submit

July 12, 2010

Conditions

Cesarean Section

Outcome Measures

Primary Outcomes (1)

  • Cumulative intravenous morphine consumption

    48 hours

Secondary Outcomes (2)

  • Postoperative pain intensity at rest and mobilization

    admission, 3,6,12,24,36,48h

  • adverse effects (nausea, vomiting, itching, sedation)

Study Arms (2)

Continuous wound infusion above the fascia

ACTIVE COMPARATOR
Procedure: Continuous wound infusion

Continuous wound infusion below the fascia

ACTIVE COMPARATOR
Procedure: Continuous wound

Interventions

Continuous wound infusionPROCEDURE
Continuous wound infusion above the fascia
Continuous woundPROCEDURE
Continuous wound infusion below the fascia

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective Cesarean Section under spinal anesthesia over37 weeks' gestation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cochin

Paris, 75014, France

Location

Related Publications (1)

  • 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.

    PMID: 20859153DERIVED

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 12, 2010

First Posted

July 13, 2010

Study Start

October 1, 2007

Primary Completion

September 1, 2008

Study Completion

December 1, 2008

Last Updated

July 13, 2010

Record last verified: 2007-09

Locations

FR(1)