Efficacy of Extended-Release Liposomal Bupivacaine for Post-Operative Urogynecologic Surgery

Walter Reed National Military Medical Center

Status and phase: Unknown; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Extended-Release liposomal bupivacaine (Exparel); Drug: Normal saline

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02287246

399635

Details and patient eligibility

About

To study post-operative efficacy of Exparel® for pain control in patients undergoing any Urogynecology surgery involving the posterior vaginal wall using a randomized, double-blinded placebo controlled trial.

Full description

Effective post-operative pain management is a crucial component of a patient's surgical course following Urogynecologic surgery. Narcotics are the cornerstone for post-operative analgesia with a frequent re-dosing requirement, a lengthy list of side effects and adverse reaction risks5. The colorectal, orthopedic and general surgery literatures have reported on an extended-release bupivacaine liposomal injection, Exparel®, which remarkably reduces acute post-operative pain; however, this medication has not yet been reported within Urogynecology literature.

We propose a prospective, randomized, double blind, placebo controlled trial with 120 subjects recruited from the WRNMMC Urogynecology Clinic to study post-operative efficacy of Exparel® for pain control in patients undergoing Urogynecology surgery involving the posterior vaginal wall. Subjects will be randomized to receive either 20mL of extended-release bupivacaine or 20mL placebo.

The primary objective of the trial will be to evaluate the cumulative post-operative vaginal pain using front side of Defense and Veterans Pain Rating Scale16 at days 1 and 3 post-procedure.. We hypothesize a 30% difference in post-operative pain measurements between the active medication group and placebo group.

Additional objectives of this study are to evaluate vaginal pain on post-operative day 7, total medication usage on days 1, 3 and 7 and any post-operative voiding dysfunction, comparing the study group to the control.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Females >18 years of age undergoing Urogynecologic surgery involving the posterior vaginal wall mucosa or muscularis (including but not limited to posterior colporrhaphy, colpocleisis, sphincter repair, sphincteroplasty, perineoplasty) at Walter Reed National Military Medical Center. Patients must be able to read and understand written English or have an appropriate certified medical translator available.

Exclusion criteria

Known allergy to amide local anesthetics Unstable cardiac arrhythmia Hepatic impairment (including but not limited to patients under the care of their physician for severe hepatic disease, cirrhosis or hepatic cancer) Known pregnancy at time of surgery (pregnancy test morning of surgery if applicable) Regular use of narcotic pain medication, defined as use on most days of week at any time in the three months prior to surgery Significant history of opioid or alcohol abuse or addiction (requiring treatment) Concurrent pain management requiring the use of epidural anesthesia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Extended-Release liposomal bupivacaine

Experimental group

Description:

20mL Extended-release liposomal bupivacaine injected into the posterior vaginal wall following surgery

Treatment:

Drug: Extended-Release liposomal bupivacaine (Exparel)

Placebo (normal saline)

Active Comparator group

Description:

20mL normal saline injected into the posterior vaginal wall following surgery

Treatment:

Drug: Normal saline