Recruiting

Liposomal Bupivacaine vs. Standard Treatment

Sponsor:

Atlantic Health System

Code:

NCT03664986

Conditions

Vaginal Prolapse

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Liposomal Bupivacaine

Study Details

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

Study ID

NCT03664986

Start date

Sep 24, 2018

Status verified date

May, 2021

Completion date

Dec 1, 2021

Anticipated

Primary completion date

Dec 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exparel pudendal block

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

no intervention: Comparison group

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

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.

Primary outcome measure

  • Pain on postoperative day one [ Time Frame: 24 hours post operative ]

Central Contacts and Locations

Central contacts

Ricardo Caraballo, MD

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

Caroline Sabatino, MPH, CCRP

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

Locations

Atlantic Health System

Recruiting

Morristown, New Jersey, United States, 07960

Principal Investigator:

Ricardo Caraballo, MD

More Information

Sponsor

Atlantic Health System

Last update posted

May 10, 2021

Last verified

May, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Atlantic Health System on 2021-05-10.