Timing of TAP Blocks in Bariatric Surgery

NCT06270147 | Recruiting Phase 2

• 1 other identifier: 16935
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to determine the optimal timing for administering a Transversus Abdominis Plane (TAP) block in bariatric surgery, specifically investigating whether initiating TAP blocks at the beginning of surgery is more beneficial than at the end, which is the current practice. The study targets obese patients undergoing bariatric surgery, with a focus on reducing postoperative pain and opioid use. Key outcomes include recovery duration, pain levels, opioid consumption, and respiratory function. Successful results could establish early TAP block initiation as a standard practice, offering faster recovery, decreased opioid reliance, and reduced healthcare costs.

Conditions

Opioid Use; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  Opioid Consumption in the post- anesthetic recovery unit

  Immediately post-op

Secondary Outcomes (6)

• Length of Stay

  immediately post-operative

• Anesthesia requirements

  Intra-operatively

• Sedation requirements

  post-operative up to 24 Hours

• Nausea and vomiting

  post-operative up to 24 Hours

• Respiratory Status

  immediately post-operative

Study Arms (2)

Early TAP block

EXPERIMENTAL

Patients in this group will receive TAP blocks at the beginning of the procedure

Drug: Bupivacaine-epinephrine

Late TAP block

ACTIVE COMPARATOR

Patients in this group will receive TAP blocks at the end of their procedure, which is the current standard practice.

Drug: Bupivacaine-epinephrine

Interventions

Bupivacaine-epinephrine DRUG

A total of 60ml of 0.25% Bupivacaine with Epinephrine, divided into 4 aliquots, will be administered laparoscopically at two locations per side along the anterior axillary line between the costal margin and the iliac crest. TAP block timing will be disclosed to the operating surgeon to ensure the correct solution is administered at the appropriate time.

Early TAP block; Late TAP block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing primary bariatric surgery at St. Joseph's Healthcare Hamilton surgery including Sleeve Gastrectomy (SG) or Roux-en-Y Gastric Bypass Surgery (RYGB)
• Patients \>18 Years of Age

You may not qualify if:

• Patients undergoing a revisional bariatric surgery
• Patients with a history of chronic pain or opioid use.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton - Charlton Campus

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 21, 2024
• Study Start: November 21, 2024
• Primary Completion: January 31, 2025
• Study Completion: June 28, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)