Transversus Abdominis Plane Blocks With Abdominoplasty

Post Operative Pain Clinical Trial

— TAPA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01278264
• Other study ID #: ANESAB001
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 14, 2011
• Last updated: April 26, 2011
• Start date: June 2011
• Est. completion date: August 2012

Study information

• Verified date: February 2011
• Source: Clinique Saint-Jean, Bruxelles
• Contact: Arnaud G Bosteels, MD
• Phone: 02 221 97 62
• Email: Abosteels[@]clstjean.be
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

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
• Ropivacaine 0.25%, 0.5 ml/kg
Subcostal approach for TAP: US guided needle insertion in the transversus abdominis plane, lateral to rectus sheet

Locations

Country	Name	City	State
Belgium	Clinique Saint Jean	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Saint-Jean, Bruxelles

Country where clinical trial is conducted

Belgium, 

References & Publications (9)

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

5. McDonnell J. Ultrasound guided abdominal wall blocks. X Annual BARA meeting -Brussels, Belgium, 2010

6. McDonnell J. XXIX Annual ESRA congress - Porto, Portugal, 2010.

7. Blanco R. TAP block under ultrasound guidance: the description of a

Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313. — View Citation

Charlton S, Cyna AM, Middleton P, Griffiths JD. Perioperative transversus abdominis plane (TAP) blocks for analgesia after abdominal surgery. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD007705. doi: 10.1002/14651858.CD007705.pub2. Review. — View Citation

Griffiths JD, Barron FA, Grant S, Bjorksten AR, Hebbard P, Royse CF. Plasma ropivacaine concentrations after ultrasound-guided transversus abdominis plane block. Br J Anaesth. 2010 Dec;105(6):853-6. doi: 10.1093/bja/aeq255. Epub 2010 Sep 22. — View Citation

Ingrande J, Lemmens HJ. Dose adjustment of anaesthetics in the morbidly obese. Br J Anaesth. 2010 Dec;105 Suppl 1:i16-23. doi: 10.1093/bja/aeq312. Review. — View Citation

Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption	Consumption measured by the use of the PCA pump	48 hours	No
Secondary	VAS score		48 hours	No
Secondary	Post operative nausea and vomiting		48 hours	No
Secondary	Constipation		48 hours	No
Secondary	Pruritus		48 hours	No
Secondary	First time to get up		48 hours	No
Secondary	First time to eat		48 hours	No