CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 219 enrolled
Drug / intervention
Liposomal Bupivacaine TAP block +1 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • Obese patients undergoing bariatric surgery (laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass)
  • Age 18 years or older
  • Surgical treatment between 01/01/2018 and 12/31/2018
Key exclusion· 10
  • Age under 18 years
  • Opioid use within 30 days of enrollment
  • History of chronic pain
  • Current use of pregabalin or gabapentin

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03373591
NCT03373591Phase 2Completed

Randomized Controlled Trial Investigating Use of Liposomal Bupivacaine in Bariatric Surgery

Montefiore Medical Center·interventional·Posted Dec 14, 2017·Updated Nov 4, 2019

In Brief

A Phase 2 clinical trial evaluating Liposomal Bupivacaine TAP block and Bupivacaine TAP block for Bariatric Surgery Analgesia. Completed, enrolled 219 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 14, 2017
Enrollment StartJan 30, 2018
Primary CompletionJun 30, 2018
Study CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.5 years ago

Interventions

Liposomal Bupivacaine TAP blockdrug

Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.

Bupivacaine TAP blockdrug

Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.