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

Vaginal Prolapse Clinical Trial

Official title:

Pudendal Block Using Liposomal Bupivacaine vs. Standard Treatment During Sacrospinous Ligament Fixation: a Prospective Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03664986
• Other study ID #: 1191772
• Status: Recruiting
• Phase: Phase 4
• Start date: September 24, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: May 2021
• Source: Atlantic Health System
• Contact: Ricardo Caraballo, MD
• Phone: 973-971-7267
• Email: ricardo.caraballo[@]atlantichealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Various clinical studies have indicated that preemptive analgesia can effectively reduce pain as well as analgesic requirements in the post-operative period. Pudendal nerve blockade has been used successfully for multiple urological procedures to prevent post-operative pain. It has also been used in obstetrical practice as a low-risk and low-cost anesthetic technique during repair of obstetrical lacerations.

Postoperative pain after vaginal reconstructive surgery is commonly localized to the vulva, lower vagina, and perineum, originating from the region of the sacrospinous ligament and pelvic floor. Therefore, pudendal nerve blockage has been employed safely during pelvic reconstructive surgery. A study comparing pudendal block with placebo after transvaginal reconstructive surgery did not produce any differences in post-operative pain intensity or the consumption of narcotic analgesia. However, the anesthetic used for the pudendal nerve blockage was short-acting non-liposomal bupivacaine with a half-life of 2.7 hours.

In 2011, a liposomal formulation of bupivacaine, EXPAREL, was approved by the FDA for single-dose infiltration in surgical site to produce postsurgical analgesia. The advantage of using this formulation of bupivacaine is that its analgesic effects can last up to 72 hours. Since the release of EXPAREL, there have been no published studies establishing its use for pudendal block or the management of postoperative pain in Urogynecologic surgery.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prolapse
• Uterine Prolapse
• Vaginal Prolapse

Intervention

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.

Locations

Country	Name	City	State
United States	Atlantic Health System	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain on postoperative day one	Pain on postoperative day one using the VAS (0 to 10 cm)	24 hours post operative
Secondary	Pain at the time of answering survey each day	Pain at the time of answering survey each day [Time frame: post-operative days 1-3 and 7] using VAS (0 to 10 cm). (Self-reported via survey or telephone call)	Daily post-op days 1-3 and 7
Secondary	Most intense pain each day	Most intense pain each day [Time frame: post-operative days 1-3 and 7] using VAS (0 to 10 cm). (Self-reported via survey or telephone call)	Daily post-op days 1-3 and 7
Secondary	Average pain each day	Average pain each day [Time frame: post-operative days 1-3 and 7] using VAS (0 to 10 cm). (Self-reported via survey or telephone call)	Daily post-op days 1-3 and 7
Secondary	Pain with sitting	Pain with sitting [Time frame: post-operative days 1-3 and 7] using VAS (0 to 10 cm). (Self-reported via survey or telephone call)	Daily post-op days 1-3 and 7
Secondary	Pain with first bowel movement	Pain with first bowel movement using VAS (0 to 10 cm). (Self-reported via survey or telephone call)	At time of first bowel movement
Secondary	Total narcotic consumption	Total narcotic consumption	up to 30 days post operative
Secondary	Urinary retention	Incidence of Urinary Retention	up to 30 days post operative
Secondary	Time to first bowel movement	Time to first bowel movement	up to 10 days post-operative
Secondary	Ambulatory Quality of Life questionnaire (QoR)	Quality of Life as measured by the ambulatory QoR [Time frame: pre-operative on the day of surgery and post-operative day 3].	up to 24 hours before surgery and 72 hours post operative