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NCT Number: NCT06270147

Timing of TAP Blocks in Bariatric Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Joseph's Healthcare Hamilton - Charlton Campus

Hamilton, Ontario, L8N 4A6, Canada

Location status: Recruiting

Location contact

Vanessa Boudreau, MD

CONTACT

[email protected]

905-522-1155 X35148

About this study

Post-operative pain remains a critical aspect of patients' recovery, with approximately 70% of patients who undergo surgery reporting moderate to severe levels of pain post-operatively. Increased post-operative pain has adverse effects on psychological and physiological function including cardiovascular, respiratory, gastrointestinal, immune function and wound healing. In an era where patient centered care is at its peak and healthcare resources are limited, adequate post-operative pain management is crucial. It facilitates early mobilization, reduces the length of stay in hospital and overall costs on the healthcare system.

The transversus abdominis plane (TAP) block, a peripheral nerve block, has been shown to significantly reduce postoperative opioid requirements, even in the context of minimally invasive surgery (MIS). Furthermore, the literature clearly indicates the benefit of TAP blocks on post-operative analgesia in patients undergoing bariatric surgery. However, evidence regarding the ideal timing of TAP block administration in the bariatric population is lacking. In current practice, TAP blocks are generally administered after the surgery, and occasionally after induction of anesthesia. However emerging studies suggest that administering TAP blocks at the beginning of a procedure may result in superior recovery and pain control in the immediate period following open and laparoscopic surgery compared to at the end of a procedure.

The purpose of the study is to assess the timing of TAP block administration in bariatric surgery patients on the immediate post-operative recovery period. This will be determined by the amount opioids required in the post-anesthetic recovery unit (PACU). Post-operative pain increases the incidence of nausea/vomiting, oxygen requirements and thus, consequently becoming a major barrier to recovery. If found to be effective, post-induction TAP blocks could become the standard of care for regional anesthesia following laparoscopic bariatric surgery and could reduce intra-operative anesthetic and opioid use, opioid consumption in (PACU), post-operative nausea and vomiting and overall length of stay in PACU. This in turn will improve patient's recovery, reduce delays in PACU and decrease patient's length of stay in the hospital.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Opioid Consumption

    Time frame: Immediately post-op

    Opioid Consumption in the post- anesthetic recovery unit

Secondary outcomes

  1. Length of Stay

    Time frame: immediately post-operative

    Length of Stay in post- anesthetic recovery unit

  2. Anesthesia requirements

    Time frame: Intra-operatively

    Intraoperative Anesthesia consumption

  3. Sedation requirements

    Time frame: post-operative up to 24 Hours

    Level of Sedation in Post-operative recovery unit

  4. Nausea and vomiting

    Time frame: post-operative up to 24 Hours

    Incidence of post operative nausea and vomiting

  5. Respiratory Status

    Time frame: immediately post-operative

    Respiratory Status in Post-operative Recovery Unit

  6. Opioid consumption

    Time frame: 24 hours post-operative

    Opioid consumption in the first 24 hours

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

Single Blind Clinical Trial: Optimizing TAP Block Timing for Bariatric Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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