Status:
COMPLETED
Comparing TAP Blocks Bupivacaine, and Placebo for Plane
Lead Sponsor:
Edward Mascha
Conditions:
Abdominal Surgery
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The study will prospectively compare the analgesic efficacy of TAP blocks with liposomal bupivacaine, plain bupivacaine, and placebo in patients who are scheduled for major abdominal surgery. The prim...
Detailed Description
The investigators propose a randomized double-blind trial comparing TAP blocks with liposomal bupivacaine, plain bupivacaine, and placebo in patients having elective abdominal surgery. After eligibil...
Eligibility Criteria
Inclusion
- Written informed consent;
- 18-85 years old;
- ASA Physical Status 1-3;
- Scheduled for elective open or laparoscopic-assisted abdominal surgery;
- Anticipated hospitalization of at least three nights;
- Expected requirement for parenteral opioids for at least 72 hours for postoperative pain;
- Able to use IV PCA systems.
Exclusion
- Hepatic disease, e.g. twice the normal levels of liver enzymes;
- Kidney disease, e.g. twice the normal level of serum creatinine;
- Bupivacaine sensitivity or known allergy;
- Women who are pregnant or breastfeeding;
- Anticoagulants considered to be a contraindication for TAP blocks;
- Surgeries with high port sites;
- Weight \<50 kg.
Key Trial Info
Start Date :
June 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2024
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT04685876
Start Date
June 4 2021
End Date
February 20 2024
Last Update
August 27 2025
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195