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

NCT ID: NCT03367728

Last Updated: 2019-11-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-27
• Study Completion Date: 2020-02-29

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

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.

Conditions

Bariatric Surgery Candidate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

TAP and Rectus Sheath Block Injections of Normal Saline

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.

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

TAP and Rectus Sheath Block Injections of Ropivacaine

Interventions

Ropivacaine

TAP and Rectus Sheath Block Injections of Ropivacaine

Intervention Type: DRUG

Normal saline

TAP and Rectus Sheath Block Injections of Normal Saline

Intervention Type: DRUG

Other Intervention Names

NAROPIN®; 84057-95-4; Sodium Chloride; 7647-14-5

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Mamazza, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Joseph Mamazza, MD

Role: CONTACT

jmamazza@toh.ca

613-798-5555 ext. 13151

Amer Jarrar, MBBCh

Role: CONTACT

ajarrar@toh.ca

613-798-5555 ext. 18230

Facility Contacts

Amer Jarrar, MBBCh

Role: primary

ajarrar@toh.ca

613-798-5555 ext. 18230

References

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.

Reference Type: DERIVED

PMID: 32595142 (View on PubMed)

Other Identifiers

20170749-01H

Identifier Type: -

Identifier Source: org_study_id