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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Atlantic Health System
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• Age >18 years

• Female

• Able to give informed consent in English

• Electively scheduled for surgical management of pelvic organ prolapse involving sacrospinous ligament fixation

Exclusion Criteria:

• 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)