Randomised, double-blinded, placebo-controlled trial to investigate the role of laparoscopic transversus abdominis plane block in gastric bypass surgery: a study protocol

Abstract

IntroductionEvaluating the efficacy of a laparoscopically guided, surgical transversus abdominis plane (TAP) and rectus sheath (RS) block in reducing analgesic consumption while improving functional outcomes in patients undergoing laparoscopic bariatric surgery.Methods150 patients Living with obesity undergoing elective laparoscopic Roux-En-Y gastric bypass for obesity will be recruited to this double-blinded, placebo-controlled randomised controlled trial from a Bariatric Centre of Excellence over a period of 6 months. Patients will be electronically randomised on a 1:1 basis to either an intervention or placebo group. Those on the intervention arm will receive a total of 60 mL 0.25% ropivacaine, divided into four injections: two for TAP and two for RS block under laparoscopic visualisation. The placebo arm will receive normal saline in the same manner. A standardised surgical and anaesthetic protocol will be followed, with care in adherence to the Enhanced Recovery after Bariatric Surgery guidelines.AnalysisDemographic information and relevant medical history will be collected from the 150 patients enrolled in the study. Our primary efficacy endpoint is cumulative postoperative narcotic use. Secondary outcomes are peak expiratory flow, postoperative pain score and the 6 min walk test. Quality of recovery (QoR) will be assessed using a validated questionnaire (QoR-40). Statistical analysis will be conducted to assess differences within and between the two groups. The repeated measures will be analysed by a mixed modelling approach and results reported through publication.Ethics and disseminationEthics approval was obtained (20170749-01H) through our institutional research ethics board (Ottawa Health Science Network Research Ethics Board) and the study results, regardless of the outcome, will be reported in a manuscript submitted for a medical/surgical journal.Trial registration numberPre-results NCT03367728.

Benefits of Transversus Abdominis Plane Block on Postoperative Analgesia after Bariatric Surgery: A Systematic Review and Meta-Analysis

“…TAP blocks have other advantages over fascial or plane blocks, as they can be safely performed under general anesthesia (66). Although our results suggest that TAP blocks should be considered for routine use, it is necessary and would be advantageous to look for larger RCTs to establish their evidence, such as the proposed study by Jarrar, et al (62).…”

“…We also observed that time to ambulate was significantly lower in the TAP group. Decreased time to ambulate facilitates recovery, hence we note that the ERAS society makes strong recommendations for its use in minimally invasive colonic surgery, even with moderate quality of evidence (62). This must be contrasted with other opioid-sparing agents, such as gabapentinoids (63) or infusions of dexmedetomidine (64,65), which can cause sedation and increase time of discharge from recovery, affecting ERAS negatively.…”

Perioperative Pain Management in Bariatric Anesthesia

“…These interventions, including the 6-min walk test and peak expiratory flow rate, are intended to concurrently prepare patients, engage them in their own care, and improve their functional status before bariatric surgery. [ 3 4 ]…”

“…Ongoing work at our center and elsewhere are looking at how better education can help set realistic expectations for the postoperative period with regards to reducing pain, analgesic requirements, and expected side effects. [ 3 4 5 ] For this, we have seen the evolution of patient education from hard copy booklets and web-based programs to app-based interactive modules providing patients in contemporary bariatric programs with the necessary tools to have the best possible experience and outcomes.…”

“…Bariatric anesthesia has provided the opportunity to study and standardize perioperative pain management protocols. [ 3 4 5 5 ] The recently enhanced recovery after surgery (ERAS) society guidelines for bariatric anesthesia have also emphasized the need for protocol standardization and implementation. [ 6 ]…”