Randomized, Double-Blinded, Placebo-Controlled Trial of Laparoscopic Transverse Abdominis Plane (Lap TAP) and Rectus Sheath Block in elective Gastric Bypass Surgery aiming to evaluate the benefit of a laparoscopically -guided, surgical transversus abdominis plane (TAP) block and rectus sheath block in reducing post-operative opioid consumption and improving outcomes in patients undergoing laparoscopic gastric bypass surgery. The results of this study will provide further evidence on the optimal means to obtain analgesia in patients undergoing gastric bypass surgery
Management of post-operative pain remains a major challenge and an area of continued research. Effective pain control, apart from providing general patient comfort, is critical for a variety of clinical reasons. It leads to early ambulation and improved respiratory function, which significantly reduces the risk of post-operative complications such as pulmonary embolus or pneumonia, as well as early discharge. Post-operative pain management was typically opioid-based; however, post-operative opioid use may be associated with increased risk of respiratory depression and sedation. It is therefore desirable to implement opioid sparing multimodal analgesia to achieve satisfactory pain control while reducing post-operative opioid requirements and their side-effects. Rational pain management is a particularly pertinent issue in the patients with morbid obesity (MO). The pathophysiology of obesity, the high prevalence of obstructive sleep apnea, and high susceptibility to respiratory depression amongst patients with MO make safe analgesic (pain) management especially difficult. These individuals are at high risk of post-operative adverse respiratory events, nosocomial infections, cardiovascular complications, and pulmonary emboli (the second leading cause of death in the bariatric surgery population). Given the increasing number of patients with MO presenting for elective weight loss surgery, it is important to understand and optimize the analgesic requirements of this patient population. However, there are limited evidence-based recommendations and no ideal analgesic regimen exists for patients with MO. Current recommendations include use of step-wise severity-based opioid- sparing multimodal analgesia. It is possible that including local anesthetic blocks will further reduce pain, opioid analgesic consumption and side-effects from pain management (sedation, confusion, nausea \& vomiting etc.) at-risk patient population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
TAP and Rectus Sheath Block Injections of Ropivacaine
TAP and Rectus Sheath Block Injections of Normal Saline
The Ottawa Hospital
Ottawa, Ontario, Canada
RECRUITINGCumulative postoperative narcotic use
Cumulative postoperative narcotic use administered within a max of 24 post operatively
Time frame: Hour 0-24 post operatively
Peak Expiratory flow score
measured by the spirometry 60 - 850 liters per minute. Peak expiratory force has not been studied extensively in obese patients. Currently, there is no recommendation on what constitutes a clinically significant change. Recovery to baseline will be sought.
Time frame: Hour 0-24 post operatively
Post-operative pain score
measured by the 0-10 Numeric pain rating score
Time frame: Hour 0-24 post operatively
6-minute walk distance (6MWD)
the distance (m) an individual is able to walk along a flat 30 m walkway over a six-minute period, with breaks as required
Time frame: 0-24 Hour post operatively
Quality of Life Questionnaire (QOR-40)
Assessment of different aspects of quality of life using validated questionnaire
Time frame: 0-24 Hour post operatively
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