- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03367728
The Use of Laparoscopic Transversus Abdominis Plane Block in Gastric Bypass Surgery (LapTAP) (LapTAP)
Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Role of Laparoscopic Transversus Abdominis Plane Block in Gastric Bypass Surgery (LapTAP Trial)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
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
Investigators
- Principal Investigator: Joseph Mamazza, MD, The Ottawa Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20170749-01H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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