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Clinical Trials/NCT03657979
NCT03657979
Completed
Phase 4

Transversus Abdominis Plane (TAP) Block in Open Abdominal Aortic Surgery : Randomized Controlled Doubled-blind Trial Comparing Ropivacaine 0.2% Versus Placebo

Centre Hospitalier Universitaire Dijon1 site in 1 country50 target enrollmentSeptember 5, 2011

Overview

Phase
Phase 4
Intervention
Ropivacaine
Conditions
Aortic Aneurysm, Abdominal
Sponsor
Centre Hospitalier Universitaire Dijon
Enrollment
50
Locations
1
Primary Endpoint
Evaluation of morphine consumption at 24 postoperative hours
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The primary outcome of this study was the evaluation of the efficacy of TAP block on pain intensity following open abdominal aortic surgery.

Registry
clinicaltrials.gov
Start Date
September 5, 2011
End Date
August 29, 2012
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eric STEINMETZ

Professor

Centre Hospitalier Universitaire Dijon

Eligibility Criteria

Inclusion Criteria

  • Open abdominal aortic surgery (aneurysm or aortobifemoral bypass)
  • Person who has given his written consent

Exclusion Criteria

  • Emergency surgery
  • Patient with infection
  • Use of opioids in the long term
  • History of chronic pain
  • Higher functions incompatible with the functioning of the PCA
  • Patients under guardianship

Arms & Interventions

Ropivacaine

Conventional PCA morphine +TAP-block ropivacaine 0.2%

Intervention: Ropivacaine

TAP-block with placebo

Conventional PCA morphine treatment with TAP-block with placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Evaluation of morphine consumption at 24 postoperative hours

Time Frame: 24 hours

Morphine consumption (Patient Controlled Analgesia) statement during the first 24 postoperative hours

Secondary Outcomes

  • Evaluation of Visual Analogue Scale scores at 24 postoperative hours(24 hours)

Study Sites (1)

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