Timing of TAP Blocks in Bariatric Surgery

November 22, 2024 updated by: McMaster University

Single Blind Clinical Trial: Optimizing TAP Block Timing for 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Recruiting
        • St. Joseph's Healthcare Hamilton - Charlton Campus
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Early TAP block
Patients in this group will receive TAP blocks at the beginning of the procedure
Drug: 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.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Opioid Consumption
Time Frame: Immediately post-op
Opioid Consumption in the post- anesthetic recovery unit
Immediately post-op

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of Stay
Time Frame: immediately post-operative
Length of Stay in post- anesthetic recovery unit
immediately post-operative
Anesthesia requirements
Time Frame: Intra-operatively
Intraoperative Anesthesia consumption
Intra-operatively
Sedation requirements
Time Frame: post-operative up to 24 Hours
Level of Sedation in Post-operative recovery unit
post-operative up to 24 Hours
Nausea and vomiting
Time Frame: post-operative up to 24 Hours
Incidence of post operative nausea and vomiting
post-operative up to 24 Hours
Respiratory Status
Time Frame: immediately post-operative
Respiratory Status in Post-operative Recovery Unit
immediately post-operative
Opioid consumption
Time Frame: 24 hours post-operative
Opioid consumption in the first 24 hours
24 hours post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16935

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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