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

NCT ID: NCT03664986

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-24
• Study Completion Date: 2021-12-01

Brief 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.

Detailed 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.

Conditions

Vaginal Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exparel pudendal block

This group will have intra-operative pudendal block performed with Liposomal Bupivacaine (EXPAREL) solution.

Group Type: EXPERIMENTAL

Liposomal Bupivacaine

Intervention Type: DRUG

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.

Comparison group

This group will be those to receive current standard treatment with no pudendal block performed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Exparel

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Atlantic Health System

OTHER

Sponsor Role: lead

Responsible Party

Ricardo Caraballo, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Atlantic Health System

Morristown, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ricardo Caraballo, MD

Role: CONTACT

ricardo.caraballo@atlantichealth.org

973-971-7267

Caroline Sabatino, MPH, CCRP

Role: CONTACT

caroline.sabatino@atlantichealth.org

973-971-7361

Facility Contacts

Caroline Sabatino, MPH, CCRP

Role: primary

References

Ezzedine D, Dhariwal L, Wasenda E, Salamon C, Caraballo R. Pudendal Nerve Block With Liposomal Bupivacaine for Sacrospinous Ligament Suspension. Urogynecology (Phila). 2024 Feb 1;30(2):98-106. doi: 10.1097/SPV.0000000000001397. Epub 2023 Jul 13.

Reference Type: DERIVED

PMID: 37450670 (View on PubMed)

Other Identifiers

1191772

Identifier Type: -

Identifier Source: org_study_id