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

NCT03664986 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2021-05-10

No results posted yet for this study

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.

Conditions

  • Vaginal Prolapse

Interventions

DRUG

Liposomal Bupivacaine

The objective of our study is to compare the use of EXPAREL in minimizing post-operative pain after sacrospinous ligament fixation with or without concomitant procedures for pelvic organ prolapse, with or without suburethral sling. We hypothesize that pudendal nerve blockage using long-acting EXPAREL will reduce post-operative pain and potentially reduce oral narcotic consumption. It may also reduce the incidence of postoperative constipation and patient satisfaction.

Sponsors & Collaborators

  • Atlantic Health System

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-24
Primary Completion
2021-12-01
Completion
2021-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03664986 on ClinicalTrials.gov