Opioid UsePhase 2NCT06270147
Timing of TAP Blocks in Bariatric Surgery
A Phase 2 study testing Bupivacaine-epinephrine in people with Opioid Use and Pain, Postoperative, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use, Pain, Postoperative
- What is being tested?
- Bupivacaine-epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 21 Nov 2024to 28 Jun 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients undergoing a revisional bariatric surgery
- Patients with a history of chronic pain or opioid use.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Healthcare Hamilton - Charlton Campus
Hamilton, Ontario, L8N 4A6
Vanessa Boudreau, MD, 905-522-1155 X35148, boudreav@mcmaster.ca
About this study
Official title: 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.
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.
- Conditions
- Opioid Use, Pain, Postoperative
- Being tested
- Bupivacaine-epinephrine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-epinephrineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Early TAP block | Experimental | Patients in this group will receive TAP blocks at the beginning of the procedure Receives: 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. Receives: Drug: Bupivacaine-epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
Opioid Consumption in the post- anesthetic recovery unit
Measured: Immediately post-op
Secondary outcomes (6)
Length of Stay
Length of Stay in post- anesthetic recovery unit
Measured: immediately post-operative
Anesthesia requirements
Intraoperative Anesthesia consumption
Measured: Intra-operatively
Sedation requirements
Level of Sedation in Post-operative recovery unit
Measured: post-operative up to 24 Hours
Nausea and vomiting
Incidence of post operative nausea and vomiting
Measured: post-operative up to 24 Hours
Respiratory Status
Respiratory Status in Post-operative Recovery Unit
Measured: immediately post-operative
Opioid consumption
Opioid consumption in the first 24 hours
Measured: 24 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start21 Nov 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion28 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270147
- Sponsor's protocol ID
- 16935
- Status last verified
- Nov 2024
- First submitted
- 6 Feb 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Blind Clinical Trial: Optimizing TAP Block Timing for Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06270147
- Acronym / sponsor ID
- 16935
- Conditions
- Opioid Use, Pain, Postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 28 Jun 2025 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early TAP block | Experimental | Drug: Bupivacaine-epinephrinePatients in this group will receive TAP blocks at the beginning of the procedure |
| Late TAP block | Active comparator | Drug: Bupivacaine-epinephrinePatients in this group will receive TAP blocks at the end of their procedure, which is the current standard practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients undergoing a revisional bariatric surgery
- Patients with a history of chronic pain or opioid use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine-epinephrineA 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. | Drug | Early TAP block, Late TAP block |
Primary outcome
Opioid Consumption
Time frame: Immediately post-op
Opioid Consumption in the post- anesthetic recovery unit
6 secondary outcomes
Length of Stay
Time frame: immediately post-operative
Anesthesia requirements
Time frame: Intra-operatively
Sedation requirements
Time frame: post-operative up to 24 Hours
Nausea and vomiting
Time frame: post-operative up to 24 Hours
Respiratory Status
Time frame: immediately post-operative
Opioid consumption
Time frame: 24 hours post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Opioid Use
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
St. Joseph's Healthcare Hamilton - Charlton Campus
Hamilton, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine-epinephrine in people with Opioid Use and Pain, Postoperative, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Consumption (time frame: Immediately post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.