TAP-Block in Abdominal Aortic Surgery (TAP-CACAO)

September 3, 2018 updated by: Eric STEINMETZ, Centre Hospitalier Universitaire Dijon

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon Cedex, France, 21079
        • Cardiovascular and thoracic surgery unit, CHU Dijon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ropivacaine
Conventional PCA morphine +TAP-block ropivacaine 0.2%
Drug: Ropivacaine
TAP-block Ropivacaine 0.2% during 48 hours
Placebo Comparator: TAP-block with placebo
Conventional PCA morphine treatment with TAP-block with placebo
Drug: Placebo
TAP-block with placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of morphine consumption at 24 postoperative hours
Time Frame: 24 hours
Morphine consumption (Patient Controlled Analgesia) statement during the first 24 postoperative hours
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Visual Analogue Scale scores at 24 postoperative hours
Time Frame: 24 hours
Visual Analogue Scale scores statement during the first 24 postoperative hours (minimum pain 0 - maximum pain 10)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Investigators

  • Principal Investigator: Claude GIRARD, Professor, Anesthesia unit
  • Principal Investigator: Eric STEINMETZ, Professor, Cardiovascular and thoracic surgery unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2011

Primary Completion (Actual)

August 29, 2012

Study Completion (Actual)

August 29, 2012

Study Registration Dates

First Submitted

June 29, 2018

First Submitted That Met QC Criteria

September 3, 2018

First Posted (Actual)

September 5, 2018

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 3, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-002355-34

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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