ClinicalTrials.gg
RecruitingNCT06270147Updated Nov 25, 2024

Timing of TAP Blocks in Bariatric Surgery

A Phase 2 interventional study of Bupivacaine-epinephrine in Opioid Use and Pain, Postoperative, sponsored by McMaster University. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-25.

Sponsored by McMaster University · Phase 2, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Opioid Use
  • Pain, Postoperative

Browse trials for

03

In context

Pain, Postoperative

5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.

This study's planned enrollment of 100 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

McMaster University is the lead sponsor of 738 studies on the registry; 125 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients undergoing a revisional bariatric surgery
  • Patients with a history of chronic pain or opioid use.
05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Early TAP block

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

    Drug: Bupivacaine-epinephrine

  • Active comparator
    Late TAP block

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

    Drug: Bupivacaine-epinephrine

Interventions

  • DrugBupivacaine-epinephrine

    Drug pages: Bupivacaine · Epinephrine

    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.

06

What researchers measure

Primary outcomes

  1. Opioid Consumption

    Opioid Consumption in the post- anesthetic recovery unit

    Time frame: Immediately post-op

Secondary outcomes

  1. Length of Stay

    Length of Stay in post- anesthetic recovery unit

    Time frame: immediately post-operative

  2. Anesthesia requirements

    Intraoperative Anesthesia consumption

    Time frame: Intra-operatively

  3. Sedation requirements

    Level of Sedation in Post-operative recovery unit

    Time frame: post-operative up to 24 Hours

  4. Nausea and vomiting

    Incidence of post operative nausea and vomiting

    Time frame: post-operative up to 24 Hours

  5. Respiratory Status

    Respiratory Status in Post-operative Recovery Unit

    Time frame: immediately post-operative

  6. Opioid consumption

    Opioid consumption in the first 24 hours

    Time frame: 24 hours post-operative

07

Study locations

1 of 1 sites recruiting
  • St. Joseph's Healthcare Hamilton - Charlton Campus
    Hamilton, Ontario L8N 4A6, Canada
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06270147
Responsible party
Sponsor
First posted
Feb 21, 2024
Start date
Nov 21, 2024
Primary completion
Jan 31, 2025 (estimated)
Completion
Jun 28, 2025 (estimated)
Last update
Nov 25, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Bupivacaine · Epinephrine

Start the discussion