NCT03373591

Liposomal Bupivacaine in Bariatric Surgery

Randomized Controlled Trial Investigating Use of Liposomal Bupivacaine in Bariatric Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to perform a randomized controlled trial for patients undergoing bariatric surgery, comparing the need for opiates with and without administration of a transversus abdominis plane (TAP) block using the long acting local anesthetic, liposomal bupivacaine (Exparel®). From this study, the investigators will assess whether use of long acting local anesthetic can reduce the need for opiates in the bariatric population.

Detailed description

A prospective randomized controlled trial investigating the use of long acting local anesthetic for transversus abdominis block in patients undergoing bariatric surgery at Montefiore Medical Center. Patients will be randomized to either receive an intraoperative TAP block with LB, an intraoperative TAP block with RB, or no TAP block. All participants will receive standard post-operative analgesia regimen. Pain scores will be recorded by the nursing staff as reported by the patients for 24-36 hours post surgery. Patients will be monitored for secondary post-operative complications up to the 2-week mark following intervention.

Conditions

• Bariatric Surgery Analgesia

Interventions

Type	Name	Description
DRUG	Liposomal Bupivacaine TAP block	Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
DRUG	Bupivacaine TAP block	Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.

Timeline

• Start date: 2018-01-30
• Primary completion: 2018-06-30
• Completion: 2018-12-31
• First posted: 2017-12-14
• Last updated: 2019-11-04
• Results posted: 2019-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study