drugset / Trial / NCT02969187

Bupivacaine Liposomal Injection (Exparel) for Postsurgical Analgesia in Patient Undergoing Laparoscopic Bariatric Surgery

NCT02969187 ↗

Phase 4 Completed 126 enrolled The Cleveland Clinic
RandomizedParallel-groupDouble-blindTreatment

Summary

Despite the increasing use of patient-controlled anesthesia (PCA) for postoperative pain management, efforts are continuing to find effective methods to relieve pain after abdominal surgery. Although opioid is an effective analgesic it has opioid related adverse events (ORAEs). Bupivacaine should reduce postoperative pain but it has relatively shorter duration of action. Liposome bupivacaine (Exparel) has been approved as a single dose infiltration for longer postoperative period analgesic. It provides up to 72 hours analgesia postoperatively; results in lesser opioids usage and reduce the ORAEs. Transversus abdominis plane (TAP) block is a relatively new regional anesthetic technique. TAP blocks have been performed to reduce opioid use and control pain in several laparoscopic surgical procedures, including colorectal resections, cholecystectomy and bariatric surgery. The aim of this study is to study the opiate usage, pain and nausea post laparoscopic gastric bypass or sleeve gastrectomy using Exparel versus Bupivacaine as TAP block and port sites infiltration.

Timeline

Start
2016-11
Primary completion
2018-01-31
Completion
2018-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 0.5 % Other
Subject Bupivacaine Other / unclassified 1.3 % Other
Subject Bupivacaine Other / unclassified 20 ml Other
Subject Bupivacaine Other / unclassified 30 ml Other
Subject Bupivacaine Other / unclassified 60 ml Other

Indications