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This will be a prospective, obesity-registry based, single-blind randomized controlled trial with a 1:1 allocation ratio. Specific inclusion criteria are all patients eligible to undergo a Laparoscopic sleeve gastrectomy (LSG) based on the current National Institute of Health (NIH) patient selection guidelines. Patients should be able to give consent, be deemed medically-cleared to undergo elective surgery, and tolerate general anesthesia. All enrollments and surgeries in this study will take place at the Cleveland Clinic Bariatric and Metabolic Institute. The study will consist of 2 interventions: laparoscopic sleeve gastrectomy (LSG) or robotic sleeve gastrectomy (RSG). The primary objective is early postoperative pain, but also surgeon ergonomics and patient quality of life will be compared. Additional outcomes include 30-day perioperative results, minor and major morbidities, serious adverse events, resolution of medical comorbidities, and weight loss in percent of excess weight lost (%EWL) at one year.
Approximately 120 subjects will be randomized into 1 of the following 2 treatment groups in a 1:1 ratio: Group 1: ZYNRELEF® up to 200 mg/ 6mg ( 7ml vial) via instillation at all incision sites in addition to 30 ml of 0.5% Ropivacaine + 10mg dexamethasone. Postoperatively, intermittent IV acetaminophen will be administered as per need till discharge. Group 2: 30 ml of 0.5% Ropivacaine and 10mg dexamethasone into all surgical sites and intermittent IV acetaminophen as per need till discharge. Primary Objective: To compare the efficacy and duration of analgesia achieved following the instillation of ZYNRELEF® all incision sites in addition to Ropivacaine with dexamethasone + postoperative IV acetaminophen, to the standard treatment of Ropivacaine with dexamethasone + postoperative IV acetaminophen in subjects undergoing laparoscopic sleeve gastrectomy. Secondary Objectives: 1. To evaluate additional efficacy parameters, including opioid load, in this study population. 2. To determine the impact of ZYNRELEF® on the cost of pain management. 3. To assess the time taken to resume exercise after discharge. 4. To assess the adverse events reported following the use of ZYNRELEF®.
The prevalence of obesity has tripled in the last 50 years with presently about 1.7 billion of the world population aged 18 years and over either overweight or obese.1 In the US alone, 35% of the population is obese.2 Although alternative surgical approaches are available, bariatric surgery results in substantial and durable weight reduction for the majority of patients, making it the most effective treatment for severe obesity.3 In the battle to reduce the invasiveness of bariatric procedures, laparoscopy has become the gold standard approach for virtually all bariatric surgery procedures in the years since it was first used for gastric bypass by Wittgrove and colleagues in 1993.5 Available data shows perioperative patient-oriented advantages of laparoscopy when compared with open surgery, including a shorter hospital stay, decreased postoperative pain, and enhanced postoperative recovery.6 The Agency for Healthcare Research and Quality (AHRQ) reported significant improvements in the safety of metabolic/bariatric surgery due in large part to improved surgical techniques.7 The risk of death is about 0.1%8 and the overall likelihood of major complications is about 4%.9 Performing bariatric surgery laproscopically can be demanding in many situations because of large livers and substantial visceral fat that limit the working space and make exposure, dissection, and reconstruction difficult.10 Similarly, thick abdominal walls may cause excessive torque on instruments. Under such situations, surgeons' ergonomics become a serious concern.11 Use of robotics in bariatric surgery has been evolving since Cadiere and colleagues reported the first case in 1999.12 Robotic surgery has provided the surgeons with the advantage of three-dimensional vision as well as increased dexterity and precision by downscaling surgeon's movements enabling a fine tissue dissection and filtering out physiological tremor.13 It overcomes the restraint of torque on ports from thick abdominal wall, and minimizes port site trauma by remote center technology.14 Although Roux-en-Y gastric bypass (RYGB) is considered by many to be the gold standard procedure for weight loss,4 several studies demonstrate that sleeve gastrectomy (SG) and RYGB provide comparable weight loss.15 In fact, utilization of SG significantly increased from 9.3% in 2010 to 58.2% in 2014.16