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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vaginal Prolapse
• Intervention / Treatment: Drug: Liposomal Bupivacaine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ricardo Caraballo, MD; Phone Number: 973-971-7267; Email: ricardo.caraballo@atlantichealth.org

Study Locations

• United States
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Recruiting
      • Atlantic Health System
      • Contact: Caroline Sabatino, MPH, CCRP
      • Principal Investigator: Ricardo Caraballo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exparel pudendal block; This group will have intra-operative pudendal block performed with Liposomal Bupivacaine (EXPAREL) solution.	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.; Other Names: Exparel
NO_INTERVENTION: Comparison group; This group will be those to receive current standard treatment with no pudendal block performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain on postoperative day one	Pain on postoperative day one using the VAS (0 to 10 cm)	24 hours post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Total narcotic consumption	Total narcotic consumption	up to 30 days post operative
Urinary retention	Incidence of Urinary Retention	up to 30 days post operative
Time to first bowel movement	Time to first bowel movement	up to 10 days post-operative
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

Collaborators and Investigators

• Sponsor: Atlantic Health System

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 24, 2018
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (ACTUAL): September 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases; Pathological Conditions, Anatomical; Pelvic Organ Prolapse; Prolapse; Uterine Prolapse; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 1191772

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No