NCT05537883

Transversus Abdominis Plane (TAP) Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients

Single Blinded Randomized Trial of Transversus Abdominis Plane Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate if laparoscopic Transversus Abdominis Plane (TAP) block using plain bupivacaine is equivalent to using liposomal bupivacaine in patients undergoing metabolic and bariatric surgery. The study will see if the plain bupivacaine group will be equivalent in terms of length of stay, Morphine Milligram Equivalents, Pain scores and patient satisfaction, but cost less.

Detailed description

Compared to only Bupivacaine administered via TAP block, the study will investigate the analgesia effects to patients undergoing metabolic and bariatric surgery receiving TAP block with a Liposomal Bupivacaine mixture. To determine if patients undergoing metabolic and bariatric surgery receiving TAP block with a Liposomal Bupivacaine results in pain scores, as measured by visual analogic scale (VAS), that are equivalent compared to patients receiving TAP block with Bupivacaine only. Compared to TAP block with Bupivacaine only, the study will compare opioid consumption, and other effect differences to patients undergoing metabolic and bariatric surgery receiving TAP block with Liposomal Bupivacaine. The study will explore other effects, including pain score at 48 hours, and 72 hours after surgery, total opioid consumption required post op during their one-week post op visit as measured in morphine equivalences.

Conditions

• Morbid Obesity
• Bariatric Surgery Candidate

Interventions

Type	Name	Description
DRUG	Liposomal bupivacaine	Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with liposomal bupivacaine
DRUG	Bupivacaine Injection	Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine

Timeline

• Start date: 2022-11-29
• Primary completion: 2023-12-07
• Completion: 2023-12-07
• First posted: 2022-09-13
• Last updated: 2025-06-11
• Results posted: 2025-06-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study