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

Status unconfirmed · Phase 4

Conditions studied: Vaginal Prolapse

In brief

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.

Key facts

Study ID

NCT03664986

Run by

Atlantic Health System

People needed

88

Starts

2018-09-24

Expected to finish

2021-12-01

Last updated by the study team

2021-05-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age >18 years
• Female
• Able to give informed consent in English
• Electively scheduled for surgical management of pelvic organ prolapse involving sacrospinous ligament fixation

You may not qualify if…

• Pregnant or nursing
• Allergy to amide anesthetics
• History of opioid abuse
• Severe cardiovascular, hepatic, renal disease or neurological impairment
• Long-acting opioid within 30 days or any opioid use within 24 hours before surgery
• Patients taking monoamineoxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types
• Administration of an investigational drug within 30 days before this study
• Chronic pain syndromes
• Daily NSAID or opioid use
• Contraindication to Non-steroidal anti-inflammatory drugs (NSAIDs)

Where it is running

• Atlantic Health System — Morristown, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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