Clinical trial NCT03367728: The Use of Laparoscopic Transversus Abdominis Plane Block in Gastric Bypass Surgery (LapTAP)
Official title: Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Role of Laparoscopic Transversus Abdominis Plane Block in Gastric Bypass Surgery (LapTAP Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bariatric Surgery Candidate
Keywords: Bariatric Surgery
Bariatrics
Ropivacaine
Randomized Controlled Trial
Enhanced Recovery After Bariatric Surgery
TAP Block
Rectus Sheath Block
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing Roux-en-Y gastric bypass surgery;
* Patients who able to tolerate general anesthetic and pneumoperitoneum;
* Patients who able to provide informed consent for the surgery;
* Patients over the age of 18 years;

Exclusion Criteria:

* Patient undergoing planned sleeve gastrectomy (intra-op conversion to sleeve gastrectomy after delivery of Ropivacaine/placebo will be included and analyzed using intention-to-treat approach)
* Patients with an allergy to local anesthetics
* Patients with severe underlying cardiovascular disease (ie: congestive heart failure, conduction abnormalities, and ischemic heart disease)
* Patients with chronic renal disease Stage 3 or greater (Creatinine clearance less than 60mL/min)
* Patients with hepatic dysfunction Child-Pugh Class B or C
* Patients with previous foregut surgery including esophageal, gastric, liver, and pancreas resections
* Patients weighing less than or equal to 100 kilograms as measured in the pre-admission unit
* Patients enrolled in any other study involving involve tissue biopsy.
* Patients with Chronic Pain and Chronic Opioid use- Oral Morphine Equivalent of \>100mg/day

Primary outcomes:
measure: Cumulative postoperative narcotic use
timeFrame: Hour 0-24 post operatively
Secondary outcomes:
measure: Peak Expiratory flow score
timeFrame: Hour 0-24 post operatively
measure: Post-operative pain score
timeFrame: Hour 0-24 post operatively
measure: 6-minute walk distance (6MWD)
timeFrame: 0-24 Hour post operatively
measure: Quality of Life Questionnaire (QOR-40)
timeFrame: 0-24 Hour post operatively
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Joseph Mamazza, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jarrar A, Budiansky A, Eipe N, Walsh C, Kolozsvari N, Neville A, Mamazza J. Randomised, double-blinded, placebo-controlled trial to investigate the role of laparoscopic transversus abdominis plane block in gastric bypass surgery: a study protocol. BMJ Open. 2020 Jun 28;10(6):e025818. doi: 10.1136/bmjopen-2018-025818.