drugset / Trial / NCT03875664

Extended Release Local Anesthetic for Postsurgical Pain After Posterior Colporrhaphy and Perineorrhaphy

NCT03875664 ↗

Phase 4 Completed 72 enrolled Wake Forest University Health Sciences
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2018-07-23
Primary completion
2019-03-12
Completion
2019-03-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 20 ml Other

Indications

No indication recorded.