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
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.
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.
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.
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Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
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Exclusion Criteria:
Patients in this group will receive TAP blocks at the beginning of the procedure
Drug: Bupivacaine-epinephrine
Patients in this group will receive TAP blocks at the end of their procedure, which is the current standard practice.
Drug: Bupivacaine-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.
Opioid Consumption
Opioid Consumption in the post- anesthetic recovery unit
Time frame: Immediately post-op
Length of Stay
Length of Stay in post- anesthetic recovery unit
Time frame: immediately post-operative
Anesthesia requirements
Intraoperative Anesthesia consumption
Time frame: Intra-operatively
Sedation requirements
Level of Sedation in Post-operative recovery unit
Time frame: post-operative up to 24 Hours
Nausea and vomiting
Incidence of post operative nausea and vomiting
Time frame: post-operative up to 24 Hours
Respiratory Status
Respiratory Status in Post-operative Recovery Unit
Time frame: immediately post-operative
Opioid consumption
Opioid consumption in the first 24 hours
Time frame: 24 hours post-operative
Plan to share: No
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Studies of the drugs tested here: Bupivacaine · Epinephrine