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Transversus Abdominis Plane Blocks With Abdominoplasty (TAPA)

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ClinicalTrials.gov Identifier: NCT01278264
Recruitment Status : Unknown
Verified February 2011 by Clinique Saint-Jean, Bruxelles.
Recruitment status was:  Not yet recruiting
First Posted : January 17, 2011
Last Update Posted : April 27, 2011
Sponsor:
Information provided by:
Clinique Saint-Jean, Bruxelles

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

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

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (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.
Study Start Date : June 2011
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : August 2012

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
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



Primary Outcome Measures :
  1. Morphine consumption [ Time Frame: 48 hours ]
    Consumption measured by the use of the PCA pump


Secondary Outcome Measures :
  1. VAS score [ Time Frame: 48 hours ]
  2. Post operative nausea and vomiting [ Time Frame: 48 hours ]
  3. Constipation [ Time Frame: 48 hours ]
  4. Pruritus [ Time Frame: 48 hours ]
  5. First time to get up [ Time Frame: 48 hours ]
  6. First time to eat [ Time Frame: 48 hours ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
6. McDonnell J. XXIX Annual ESRA congress - Porto, Portugal, 2010.
7. Blanco R. TAP block under ultrasound guidance: the description of a
5. McDonnell J. Ultrasound guided abdominal wall blocks. X Annual BARA meeting -Brussels, Belgium, 2010
4.O'Donnell BD, McDonnell JG, McShane AJ. The transversus abdominis plane (TAP) block in open retropubic prostatectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):91. No abstract available. Erratum in: Reg Anesth Pain Med. 2006 May-Jun;31(3):286. McDonnell, John G [added]; McShane, Alan J [added]. PMID: 16418039

Responsible Party: Arnaud G Bosteels, Service Anesthesie Clinique Saint-Jean Bruxelles
ClinicalTrials.gov Identifier: NCT01278264     History of Changes
Other Study ID Numbers: ANESAB001
First Posted: January 17, 2011    Key Record Dates
Last Update Posted: April 27, 2011
Last Verified: February 2011

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

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