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Transversus Abdominis Plane Blocks With Abdominoplasty (TAPA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Clinique Saint-Jean, Bruxelles.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Clinique Saint-Jean, Bruxelles
ClinicalTrials.gov Identifier:
NCT01278264
First received: January 14, 2011
Last updated: April 26, 2011
Last verified: February 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Post Operative Pain
 Drug: Ropivacaine 0.25%, 0.5 ml/kg
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Transversus Abdominis Plane Blocks in Patients Scheduled for an Abdominoplasty. A Prospective, Randomized, Double Blind, Comparison Between the Posterior Approach and Placebo.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Clinique Saint-Jean, Bruxelles:

Primary Outcome Measures:
  • Morphine consumption [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Consumption measured by the use of the PCA pump


Secondary Outcome Measures:
  • VAS score [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Post operative nausea and vomiting [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Constipation [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Pruritus [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • First time to get up [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • First time to eat [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Subcostal approach for TAP: US guided needle insertion in the transversus abdominis plane, lateral to rectus sheet

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278264

Contacts
Contact: Arnaud G Bosteels, MD 02 221 97 62 ext 0032 Abosteels@clstjean.be

Locations
Belgium
Clinique Saint Jean Not yet recruiting
Bruxelles, Belgium, 1000
Principal Investigator: Arnaud G Bosteels, MD            
Sponsors and Collaborators
Clinique Saint-Jean, Bruxelles
Investigators
Principal Investigator: Arnaud G Bosteels, MD Clinique Saint-Jean, Bruxelles
  More Information

Publications:
2. Petersen PL et al. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35
9. Ingrande J et al. Dose adjustment of anaesthetics in the morbidly obese. BJA 105 (S1); i16- i23 (2010)

Responsible Party: Arnaud G Bosteels, Service Anesthesie Clinique Saint-Jean Bruxelles
ClinicalTrials.gov Identifier: NCT01278264     History of Changes
Other Study ID Numbers: ANESAB001
Study First Received: January 14, 2011
Last Updated: April 26, 2011
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by Clinique Saint-Jean, Bruxelles:
Transversus abdominis plane block
Ultrasound guided
Abdominoplasty

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013