Clinical trial NCT01278264: Transversus Abdominis Plane Blocks With Abdominoplasty
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Post Operative Pain
Keywords: Transversus abdominis plane block
Ultrasound guided
Abdominoplasty
Lead sponsor: Clinique Saint-Jean, Bruxelles
Sponsor class: OTHER
First posted: 2011-01-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Morphine consumption
timeFrame: 48 hours
Secondary outcomes:
measure: VAS score
timeFrame: 48 hours
measure: Post operative nausea and vomiting
timeFrame: 48 hours
measure: Constipation
timeFrame: 48 hours
measure: Pruritus
timeFrame: 48 hours
measure: First time to get up
timeFrame: 48 hours
measure: First time to eat
timeFrame: 48 hours
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Clinique Saint Jean
Study officials:
affiliation: Clinique Saint-Jean, Bruxelles
name: Arnaud G Bosteels, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
citation: 6. McDonnell J. XXIX Annual ESRA congress - Porto, Portugal, 2010.
citation: 7. Blanco R. TAP block under ultrasound guidance: the description of a
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.
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.
citation: 5. McDonnell J. Ultrasound guided abdominal wall blocks. X Annual BARA meeting -Brussels, Belgium, 2010
citation: 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.