Medial open transversus abdominis plane (MOTAP) catheters for analgesia following open liver resection: study protocol for a randomized controlled trial

Trials

Hance Clarke³  Jenny Lam-McCulloch⁶  Srinivas Coimbatore⁵  James Khan⁵  Alex Kiss⁴  Joel Katz³  Raynauld Ko³  Natalie Coburn⁷  Alice Wei³  Calvin Law⁷  Salima Ladak³  Jason Sawyer²  Stuart McCluskey³  Paul McHardy⁵  Sean Cleary¹  Paul Karanicolas⁷ 

[1] Department of Surgery, University Health Network, Toronto, Canada;Department of Anaesthesia, Sunnybrook Health Sciences Centre, Toronto, Canada;Department of Anaesthesia and Pain Management, University Health Network, Toronto, Canada;Clinical Epidemiology Unit, Sunnybrook Research Institute, Toronto, Canada;Department of Anaesthesia, University of Toronto, Toronto, Canada;Department of Surgery, Sunnybrook Health Sciences Centre, Toronto, Canada;Department of Surgery, University of Toronto, Toronto, Canada

关键词: Randomized controlled trial;    Transversus abdominis plane;    Analgesia;    Liver surgery;   

Others  :  802573
DOI  :  10.1186/1745-6215-15-241

 received in 2014-04-23, accepted in 2014-06-05,  发布年份 2014

【 摘 要 】

Background

The current standard for pain control following liver surgery is intravenous, patient-controlled analgesia (IV PCA) or epidural analgesia. We have developed a modification of a regional technique called medial open transversus abdominis plane (MOTAP) catheter analgesia. The MOTAP technique involves surgically placed catheters through the open surgical site into a plane between the internal oblique muscle and the transverse abdominis muscle superiorly. The objective of this trial is to assess the efficacy of this technique.

Methods/design

This protocol describes a multicentre, prospective, blinded, randomized controlled trial. One hundred and twenty patients scheduled for open liver resection through a subcostal incision will be enrolled. All patients will have two MOTAP catheters placed at the conclusion of surgery. Patients will be randomized to one of two parallel groups: experimental (local anaesthetic through MOTAP catheters) or placebo (normal saline through MOTAP catheters). Both groups will also receive IV PCA. The primary endpoint is mean cumulative postoperative opioid consumption over the first 2 postoperative days (48 hours). Secondary outcomes include pain intensity, patient functional outcomes, and the incidence of complications.

Discussion

This trial has been approved by the ethics boards at participating centres and is currently enrolling patients. Data collection will be completed by the end of 2014 with analysis mid-2015 and publication by the end of 2015.

Trial registration

The study is registered withhttp://clinicaltrials.gov webcite ( NCT01960049; 23 September 2013)

【 授权许可】

   
2014 Karanicolas et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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