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The Use of Laparoscopic Transversus Abdominis Plane Block in Gastric Bypass Surgery (LapTAP) (LapTAP)

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ClinicalTrials.gov Identifier: NCT03367728
Recruitment Status : Not yet recruiting
First Posted : December 11, 2017
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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

Condition or disease Intervention/treatment Phase
Bariatric Surgery Candidate Drug: Ropivacaine Drug: Normal saline Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Role of Laparoscopic Transversus Abdominis Plane Block in Gastric Bypass Surgery (LapTAP Trial)
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Other Names:
  • Sodium Chloride
  • 7647-14-5

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.
Drug: Ropivacaine
TAP and Rectus Sheath Block Injections of Ropivacaine
Other Names:
  • NAROPIN®
  • 84057-95-4




Primary Outcome Measures :
  1. Cumulative postoperative narcotic use [ Time Frame: Hour 0-24 post operatively ]
    Cumulative postoperative narcotic use administered within a max of 24 post operatively


Secondary Outcome Measures :
  1. 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.

  2. Post-operative pain score [ Time Frame: Hour 0-24 post operatively ]
    measured by the 0-10 Numeric pain rating score

  3. 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

  4. Quality of Life Questionnaire (QOR-40) [ Time Frame: 0-24 Hour post operatively ]
    Assessment of different aspects of quality of life using validated questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Joseph Mamazza, MD 613-798-5555 ext 13151 jmamazza@toh.ca
Contact: Amer Jarrar, MBBCh 613-798-5555 ext 18230 ajarrar@toh.ca

Locations
Canada, Ontario
The Ottawa Hospital Not yet recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Amer Jarrar, MBBCh    613-798-5555 ext 18230    ajarrar@toh.ca   
Principal Investigator: Joseph Mamazza, MD FRCSC         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Joseph Mamazza, MD The Ottawa Hospital

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03367728     History of Changes
Other Study ID Numbers: 20170749-01H
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ottawa Hospital Research Institute:
Bariatric Surgery
Bariatrics
Ropivacaine
Randomized Controlled Trial
Enhanced Recovery After Bariatric Surgery
TAP Block
Rectus Sheath Block

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents