CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 72 enrolled
Drug / intervention
Liposomal bupivacaine +1 moredrug
Likely dose
Not stated in 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/NCT03875664
NCT03875664Phase 4Completed

Extended Release Local Anesthetic for Postsurgical Pain After Posterior Colporrhaphy and Perineorrhaphy: A Randomized Controlled Study

Wake Forest University Health Sciences·interventional·Posted Mar 15, 2019·Updated Sep 13, 2022

In Brief

A Phase 4 clinical trial evaluating Liposomal bupivacaine and Placebo - injection for Postoperative Pain. Completed, enrolled 72 participants across 1 site.

Detailed Summary

The specific aim of this randomized double-blind clinical trial is to evaluate the effect of intraoperative infiltration of liposomal bupivacaine at the time of posterior colporrhaphy and/or perineorrhaphy on postsurgical pain scores during the first 72 hours after surgery as measured by visual analog scales (VAS) for patients undergoing surgery for pelvic organ prolapse. Study subjects are randomized to 30 mL of liposomal bupivacaine versus 30 mL of injectable normal saline administered in a standardized technique into the posterior vaginal compartment at the time of posterior repair and/or perineorrhaphy.

Study Details

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

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedMar 15, 2019
Enrollment StartJul 23, 2018
Primary CompletionMar 12, 2019
Study CompletionMar 31, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.3 years ago

Interventions

Liposomal bupivacainedrug

Extended-release local anesthetic

Placebo - injectiondrug

Injectable normal saline solution