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

November 4, 2019 updated by: Ottawa Hospital Research Institute

Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Role of Laparoscopic Transversus Abdominis Plane Block in Gastric Bypass Surgery (LapTAP Trial)

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

Study Overview

Status

Unknown

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

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Joseph Mamazza, MD
  • Phone Number: 13151 613-798-5555
  • Email: jmamazza@toh.ca

Study Contact Backup

  • Name: Amer Jarrar, MBBCh
  • Phone Number: 18230 613-798-5555
  • Email: ajarrar@toh.ca

Study Locations

    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Recruiting
        • The Ottawa Hospital
        • Contact:
          • Amer Jarrar, MBBCh
          • Phone Number: 18230 613-798-5555
          • Email: ajarrar@toh.ca
        • Principal Investigator:
          • Joseph Mamazza, MD FRCSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative postoperative narcotic use
Time Frame: Hour 0-24 post operatively
Cumulative postoperative narcotic use administered within a max of 24 post operatively
Hour 0-24 post operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Hour 0-24 post operatively
Post-operative pain score
Time Frame: Hour 0-24 post operatively
measured by the 0-10 Numeric pain rating score
Hour 0-24 post operatively
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
0-24 Hour post operatively
Quality of Life Questionnaire (QOR-40)
Time Frame: 0-24 Hour post operatively
Assessment of different aspects of quality of life using validated questionnaire
0-24 Hour post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Joseph Mamazza, MD, The Ottawa Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2018

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

December 5, 2017

First Submitted That Met QC Criteria

December 5, 2017

First Posted (Actual)

December 11, 2017

Study Record Updates

Last Update Posted (Actual)

November 6, 2019

Last Update Submitted That Met QC Criteria

November 4, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Within 6 months of completion

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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