Transversus Abdominis Plane Blocks With Abdominoplasty (TAPA)

April 26, 2011 updated by: Clinique Saint-Jean, Bruxelles

Transversus Abdominis Plane Blocks in Patients Scheduled for an Abdominoplasty. A Prospective, Randomized, Double Blind, Comparison Between the Posterior Approach and Placebo.

Comparing morphine consumption and recovery with two different TAP block techniques after abdominoplasty.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

TAP blocks have the potential to become an important part of multi-modal analgesia after abdominal surgery (1,2). Originally Dr J McDonnell described a blind double pop technique, trough the triangle of Petit, with up to 48 hours of analgesia (3,4). Dr P Hebbard described an ultrasound based technique with a subcostal (for supra-umbilical analgesia) and an axillary mid-line injection (for sub-umbilical analgesia) in the TAP, with reported analgesia for up to 8 hours (5,6). Recently Dr J McDonnell presented data showing para vertebral spread (up to L5) of the (high dose, low concentration) local anaesthetic explaining the prolonged analgesic effect (7,8). In 2007 Dr Blanco described an ultrasound guided technique for the posterior infiltration as performed by McDonnell (9). Our limited observational comparison between both block techniques confirms this difference. We decided to compare both techniques (the ultrasound guided single shot subcostal injection, the aTAP-group (Hebbard is from Australia) and the ultrasound guided posterior injection, the iTAP-group (McDonnell is from Ireland). We will use the same volume and concentration of local anesthetic and we will asses their analgesic efficacy and improvement in quality of recovery.

Study Type

Interventional

Enrollment (Anticipated)

60

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

  • Belgium
      • Bruxelles, Belgium, 1000
        • Clinique Saint Jean

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Eligible for abdominoplasty
  • ASA 1-2
  • Fluent french/dutch/english

Exclusion Criteria:

  • History of allergy to local anaesthetics
  • Chronic opioids abuse
  • Pregnant patients

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: iTAP-group
Posterior approach for TAP: ultrasound guided bilateral needle insertion in the transversus abdominis plane, anterior to the quadratus lumborum muscle
Drug: Ropivacaine 0.25%, 0.5 ml/kg
Posterior approach for TAP: ultrasound guided bilateral needle insertion in the transversus abdominis plane, anterior to the quadratus lumborum muscle
Drug: Ropivacaine 0.25%, 0.5 ml/kg
Subcostal approach for TAP: US guided needle insertion in the transversus abdominis plane, lateral to rectus sheet
Active Comparator: aTAP-group
Subcostal approach for TAP: US guided needle insertion in the transversus abdominis plane, lateral to rectus sheet
Drug: Ropivacaine 0.25%, 0.5 ml/kg
Posterior approach for TAP: ultrasound guided bilateral needle insertion in the transversus abdominis plane, anterior to the quadratus lumborum muscle
Drug: Ropivacaine 0.25%, 0.5 ml/kg
Subcostal approach for TAP: US guided needle insertion in the transversus abdominis plane, lateral to rectus sheet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consumption
Time Frame: 48 hours
Consumption measured by the use of the PCA pump
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
VAS score
Time Frame: 48 hours
48 hours
Post operative nausea and vomiting
Time Frame: 48 hours
48 hours
Constipation
Time Frame: 48 hours
48 hours
Pruritus
Time Frame: 48 hours
48 hours
First time to get up
Time Frame: 48 hours
48 hours
First time to eat
Time Frame: 48 hours
48 hours

Collaborators and Investigators

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

Sponsor

Clinique Saint-Jean, Bruxelles

Investigators

  • Principal Investigator: Arnaud G Bosteels, MD, Clinique Saint-Jean, Bruxelles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2011

Primary Completion (Anticipated)

May 1, 2012

Study Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

January 14, 2011

First Submitted That Met QC Criteria

January 14, 2011

First Posted (Estimate)

January 17, 2011

Study Record Updates

Last Update Posted (Estimate)

April 27, 2011

Last Update Submitted That Met QC Criteria

April 26, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANESAB001

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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