drugset / Trial / NCT03664986

Pudendal Block Using Liposomal Bupivacaine vs. Standard Treatment During Sacrospinous Ligament Fixation

NCT03664986 ↗

Phase 4 Unknown 88 enrolled Atlantic Health System
RandomizedParallel-groupSingle-blindTreatment

Summary

A pudendal nerve block is a procedure where a local anesthetic is injected where the pudendal nerve is located. This allows quick pain relief to the perineum, vulva, and vagina. The purpose of this research study is see if injecting a long-acting local anesthetic, called Liposomal Bupivacaine (EXPAREL), will result in less post-operative pain after having vaginal prolapse surgery. Typical post-operative pain lasts a few days. Short-acting anesthetics only provide pain relief in the few hours after surgery. EXPAREL will add the benefit of longer acting pain relief that can last up to 72 hours with the same safety profile. EXPAREL is an FDA-approved medication. It has been used and studied extensively in gynecologic surgery for incisional pain. It has also been studied in Urology and Orthopedic surgery with an excellent safety profile with good pain relief.

Timeline

Start
2018-09-24
Primary completion
2021-12-01
Completion
2021-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified — Other