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

NCT03664986 | Unknown Phase 4 FDA Drug

• 1 other identifier: 1191772
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Prolapse

Outcome Measures

Primary Outcomes (1)

• Pain on postoperative day one

  Pain on postoperative day one using the VAS (0 to 10 cm)

  24 hours post operative

Secondary Outcomes (9)

• Pain at the time of answering survey each day

  Daily post-op days 1-3 and 7

• Most intense pain each day

  Daily post-op days 1-3 and 7

• Average pain each day

  Daily post-op days 1-3 and 7

• Pain with sitting

  Daily post-op days 1-3 and 7

• Pain with first bowel movement

  At time of first bowel movement

Study Arms (2)

Exparel pudendal block

EXPERIMENTAL

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

Drug: Liposomal Bupivacaine

Comparison group

NO INTERVENTION

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

Interventions

Liposomal Bupivacaine 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.

Also known as: Exparel

Exparel pudendal block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Atlantic Health System: lead

Study Sites (1)

Atlantic Health System

Morristown, New Jersey, 07960, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 37450670 DERIVED

MeSH Terms

Conditions

Uterine Prolapse

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ricardo Caraballo, MD

CONTACT

973-971-7267; ricardo.caraballo@atlantichealth.org

Caroline Sabatino, MPH, CCRP

CONTACT

973-971-7361; caroline.sabatino@atlantichealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The group you get randomized to will be chosen by chance, like flipping a coin. Neither you nor the study doctor will choose what group you will be in. You will have an equal chance of being in either group. Neither you nor the nurses nor anesthesiologist will know which group you will be in. However, your study doctor will know.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: September 11, 2018
• Study Start: September 24, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)