The Use of Laparoscopic Transversus Abdominis Plane Block in Gastric Bypass Surgery (LapTAP) (LapTAP)
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|ClinicalTrials.gov Identifier: NCT03367728|
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : December 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bariatric Surgery Candidate||Drug: Ropivacaine Drug: Normal saline||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Role of Laparoscopic Transversus Abdominis Plane Block in Gastric Bypass Surgery (LapTAP Trial)|
|Actual Study Start Date :||November 27, 2018|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||May 2019|
Placebo Comparator: TAP and Rectus Sheath Normal Saline
TAP and Rectus Sheath Block of 60 mL Normal Saline divided into 4 injections administered as in Experimental Arm.
Drug: Normal saline
TAP and Rectus Sheath Block Injections of Normal Saline
Experimental: TAP and Rectus Sheath ropivacaine
The block will be administered in the anterior abdominal wall. For the TAP block, the standard technique will be followed- at the anterior axillary line midway between the subcostal margin and iliac crest. For the rectus sheath block, a bilateral sub-xiphoid approach will be used. There will be 4 injection sites in total and the size of the needle will be standardized to an 18g spinal needle 10cms. Using laparoscopic visualization, the transversus abdominis muscles were identified lateral to the semilunar line. Ropivacaine to be infiltrated will be divided into 4 equal amounts. The procedure is then repeated 2 times in the transversus abdominis plane (20mL each) and 2 times as a Rectus Sheath Block (10mL each) with a total amount of 60 mL.
TAP and Rectus Sheath Block Injections of Ropivacaine
- Cumulative postoperative narcotic use [ Time Frame: Hour 0-24 post operatively ]Cumulative postoperative narcotic use administered within a max of 24 post operatively
- Peak Expiratory flow score [ Time Frame: Hour 0-24 post operatively ]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.
- Post-operative pain score [ Time Frame: Hour 0-24 post operatively ]measured by the 0-10 Numeric pain rating score
- 6-minute walk distance (6MWD) [ Time Frame: 0-24 Hour post operatively ]the distance (m) an individual is able to walk along a flat 30 m walkway over a six-minute period, with breaks as required
- Quality of Life Questionnaire (QOR-40) [ Time Frame: 0-24 Hour post operatively ]Assessment of different aspects of quality of life using validated questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367728
|Contact: Joseph Mamazza, MD||613-798-5555 ext firstname.lastname@example.org|
|Contact: Amer Jarrar, MBBCh||613-798-5555 ext email@example.com|
|The Ottawa Hospital||Recruiting|
|Ottawa, Ontario, Canada, K1Y 4E9|
|Contact: Amer Jarrar, MBBCh 613-798-5555 ext 18230 firstname.lastname@example.org|
|Principal Investigator: Joseph Mamazza, MD FRCSC|
|Principal Investigator:||Joseph Mamazza, MD||The Ottawa Hospital|