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

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.

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