drugset / Trial / NCT03723447

Intraoperative TAP Block With Bupivacaine/Dexamethasone Against Liposomal Bupivacaine (Exparel®)

NCT03723447 ↗

Phase 4 Completed 102 enrolled Cedars-Sinai Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

Traditionally, opioids are heavily utilized in treating postoperative pain but they are associated with numerous side effects. The use of the transversus abdominis plane (TAP) blocks have become standard practice to extend the post-operative analgesic window and limit opioid use. A new liposomal-depo formulation of bupivacaine (Exparel) has gained popularity as a long-lasting TAP block medication, but has not been studied in a well-powered clinical trial specifically in colorectal patients nor compared to a bupivacaine/steroid mixture which may offer similar effects. We conduct a prospective randomized prospective randomized study of patients undergoing major laparoscopic colorectal surgery to compare the analgesic effects of a bupivacaine/steroid mixture versus liposomal bupivacaine.

Timeline

Start
2018-10-23
Primary completion
2019-10-29
Completion
2019-10-29

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 266 mg —
Comparator Bupivacaine Other / unclassified — —
Comparator Dexamethasone Small molecule 8 mg —
Comparator Epinephrine Other / unclassified — —