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

NCT03367728 | Unknown Phase 4 DMC

• 1 other identifier: 20170749-01H
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Bariatric Surgery Candidate

Keywords

Bariatric Surgery; Bariatrics; Ropivacaine; Randomized Controlled Trial; Enhanced Recovery After Bariatric Surgery; TAP Block; Rectus Sheath Block

Outcome Measures

Primary Outcomes (1)

• Cumulative postoperative narcotic use

  Cumulative postoperative narcotic use administered within a max of 24 post operatively

  Hour 0-24 post operatively

Secondary Outcomes (4)

• Peak Expiratory flow score

  Hour 0-24 post operatively

• Post-operative pain score

  Hour 0-24 post operatively

• 6-minute walk distance (6MWD)

  0-24 Hour post operatively

• Quality of Life Questionnaire (QOR-40)

  0-24 Hour post operatively

Study Arms (2)

TAP and Rectus Sheath Normal Saline

PLACEBO COMPARATOR

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 ropivacaine

EXPERIMENTAL

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

Interventions

Ropivacaine DRUG

TAP and Rectus Sheath Block Injections of Ropivacaine

Also known as: NAROPIN®, 84057-95-4

TAP and Rectus Sheath ropivacaine

Normal saline DRUG

TAP and Rectus Sheath Block Injections of Normal Saline

Also known as: Sodium Chloride, 7647-14-5

TAP and Rectus Sheath Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 32595142 DERIVED

MeSH Terms

Interventions

Ropivacaine; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Joseph Mamazza, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Mamazza, MD

CONTACT

613-798-5555; jmamazza@toh.ca

Amer Jarrar, MBBCh

CONTACT

613-798-5555; ajarrar@toh.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 11, 2017
• Study Start: November 27, 2018
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: November 6, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 6 months of completion

Locations

CA (1)