The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9, Canada
NCT Number: NCT03367728
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
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Ottawa, Ontario, K1Y 4E9, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TAP and Rectus Sheath Block Injections of Ropivacaine
Other names: NAROPIN®, 84057-95-4
TAP and Rectus Sheath Block Injections of Normal Saline
Other names: Sodium Chloride, 7647-14-5
Time frame: Hour 0-24 post operatively, baseline and Follow-up use of narcotics will be recorded for population description
Cumulative postoperative narcotic use administered within 24 hours post-operatively
Time frame: Surgery consent visit, morning of surgery, Hour 0-24 post operatively, Follow-up (7-10 days post op)
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: Surgery consent visit, morning of surgery, Hour 0-24 post operatively, Follow-up (7-10 days post op)
measured by the 0-10 Numeric pain rating score
Time frame: Surgery consent visit, morning of surgery, Hour 0-24 post operatively, Follow-up (7-10 days post op)
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: Surgery consent visit, morning of surgery, Hour 0-24 post operatively, Follow-up (7-10 days post op)
Assessment of different aspects of quality of life using validated questionnaire
Ottawa Hospital Research Institute
Other
Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Role of Laparoscopic Transversus Abdominis Plane Block in Gastric Bypass Surgery (LapTAP Trial)
Acronym: LapTAP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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