drugset / Trial / NCT02296099

Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence

NCT02296099 ↗

Phase 4 Completed 114 enrolled TriHealth Inc.
RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of the study is to determine if the administration of liposomal bupivacaine at the completion of a suburethral sling procedure will result in decreased postoperative pain compared to no injection.

Timeline

Start
2014-11
Primary completion
2016-08
Completion
2016-08

Outcome

Met primary endpoint

registry analysis (equivalence test); Liposomal Bupivacaine vs Saline Placebo; p = 0.014 NCT02296099 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 266 mg Other