Comparison of Liposomal Bupivacaine, Plain Bupivacaine, and Placebo for Transversus Abdominis Plane Blocks: A Randomized, Blinded Trial

20-790

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 primary aim is to assess the duration of the local analgesia (determined by pinprick and cold) in all four quadrants. Comparing opioid consumption and pain scores is a secondary aim. All aims will be assessed over 72 hours or the duration of hospitalization if shorter.

2021-06-04

2024-12-01

2024-12-01

Recruiting

Early phase I

237

Inclusion Criteria: * 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 Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 237, 'type': 'ESTIMATED'}}

2024-01-23