Transversus Abdominis Plane Blocks With Abdominoplasty

NCT ID: NCT01278264

Last Updated: 2011-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-08-31

Brief Summary

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

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

iTAP-group

Posterior approach for TAP: ultrasound guided bilateral needle insertion in the transversus abdominis plane, anterior to the quadratus lumborum muscle

Group Type: ACTIVE_COMPARATOR

Ropivacaine 0.25%, 0.5 ml/kg

Intervention Type: DRUG

Posterior approach for TAP: ultrasound guided bilateral needle insertion in the transversus abdominis plane, anterior to the quadratus lumborum muscle

aTAP-group

Subcostal approach for TAP: US guided needle insertion in the transversus abdominis plane, lateral to rectus sheet

Group Type: ACTIVE_COMPARATOR

Ropivacaine 0.25%, 0.5 ml/kg

Intervention Type: DRUG

Subcostal approach for TAP: US guided needle insertion in the transversus abdominis plane, lateral to rectus sheet

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Clinique Saint-Jean, Bruxelles

OTHER

Sponsor Role: lead

Responsible Party

Service Anesthesie Clinique Saint-Jean Bruxelles

Principal Investigators

Arnaud G Bosteels, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Saint-Jean, Bruxelles

Locations

Clinique Saint Jean

Brussels, , Belgium

Countries

Belgium

Central Contacts

Arnaud G Bosteels, MD

Role: CONTACT

Abosteels@clstjean.be

02 221 97 62 ext. 0032

References

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.

Reference Type: BACKGROUND

PMID: 21154380 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20175754 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19020158 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 20861094 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21148651 (View on PubMed)

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

Reference Type: BACKGROUND

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. doi: 10.1016/j.rapm.2005.10.006. No abstract available.

Reference Type: BACKGROUND

PMID: 16418039 (View on PubMed)

Other Identifiers

ANESAB001

Identifier Type: -

Identifier Source: org_study_id