Clinical trial NCT03664986: Pudendal Block Using Liposomal Bupivacaine vs. Standard Treatment During Sacrospinous Ligament Fixation
Official title: Pudendal Block Using Liposomal Bupivacaine vs. Standard Treatment During Sacrospinous Ligament Fixation: a Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vaginal Prolapse
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Pain on postoperative day one
timeFrame: 24 hours post operative
Secondary outcomes:
measure: Pain at the time of answering survey each day
timeFrame: Daily post-op days 1-3 and 7
measure: Most intense pain each day
timeFrame: Daily post-op days 1-3 and 7
measure: Average pain each day
timeFrame: Daily post-op days 1-3 and 7
measure: Pain with sitting
timeFrame: Daily post-op days 1-3 and 7
measure: Pain with first bowel movement
timeFrame: At time of first bowel movement
measure: Total narcotic consumption
timeFrame: up to 30 days post operative
measure: Urinary retention
timeFrame: up to 30 days post operative
measure: Time to first bowel movement
timeFrame: up to 10 days post-operative
measure: Ambulatory Quality of Life questionnaire (QoR)
timeFrame: up to 24 hours before surgery and 72 hours post operative
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
Study officials:
References: