CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 114 enrolled
Drug / intervention
liposomal bupivacaine +1 moredrug
Likely dose
liposomal bupivacaine 20 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02296099
NCT02296099Phase 4Completed

The Impact of Liposomal Bupivacaine Administered Following Placement of a Retropubic Suburethral Sling for Stress Urinary Incontinence: a Randomized Placebo-controlled Trial

TriHealth Inc.·interventional·Posted Nov 20, 2014·Updated Aug 16, 2018

In Brief

A Phase 4 clinical trial evaluating liposomal bupivacaine and Placebo for Urinary Incontinence, Stress. Completed, enrolled 114 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 20, 2014
Enrollment StartNov 1, 2014
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.6 years ago

Interventions

liposomal bupivacainedrug

Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.

Placebodrug

Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.