drugset / Trial / NCT02574520

Trial of Extended Release Bupivacaine for Pain Relief After Surgery

NCT02574520

Phase 3 Completed 399 enrolled Durect
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a research study of SABER® -Bupivacaine, an experimental medication designed to reduce pain for up to 3 days after surgery. Given once by the surgeon at the end of surgery, SABER® - Bupivacaine delivers a locally-acting pain reliever directly to the surgical wound. The purpose of this study is to measure how well it works in reducing pain after laparoscopic cholecystectomy (surgery to remove the gall bladder) and to investigate the safety of SABER®-Bupivacaine (its side effects).

Timeline

Start
2015-11
Primary completion
2017-06
Completion
2017-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 0.5 %
Comparator Bupivacaine Other / unclassified 15 ml
Comparator SABER-Bupivacaine Unknown 5 ml

Indications

No indication recorded.