Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy
Status:
Completed
Trial end date:
2020-08-25
Target enrollment:
Participant gender:
Summary
Effective post-surgical pain management is a crucial component of a patient's postoperative
course following posterior colporrhaphy. Narcotics are the cornerstone for postoperative
analgesia with a frequent re-dosing requirement, a lengthy list of side effects and adverse
reaction risks. 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, literature regarding this medication specific to Urogynecology
and Gynecology is limited.
The investigators propose a prospective, randomized, double blind, trial with 120 subjects
recruited from the Walter Reed National Military Medical Center (WRNMMC) Urogynecology Clinic
to study postsurgical pain control after posterior repair. There will be two arms in the
study; one arm with bupivacaine alone and a second arm with bupivacaine mixed with
Exparel®(extended-release, liposomal bupivacaine) injected vaginally in patients undergoing
posterior colporrhaphy. Subjects will be randomized to receive either 20 milliliter (mL) of
plain bupivacaine or 20mL (10ml+10ml) mixture of bupivacaine plus Exparel®.
The primary objective of the trial will be to evaluate the postsurgical vaginal pain using a
visual analog pain scale at days 1, 2, 3 post-procedure. All subjects will have
acetaminophen, a non-steroidal anti-inflammatory drug and narcotic pain medication available
for pain control regardless of assignment, which is the usual postoperative pain control
regimen. The investigators hypothesize a 30% difference in post-operative pain measurements
between the two groups.
Additional objectives of this study are to evaluate total medication usage on days 1, 2 and 3
and any post-operative voiding and defecatory dysfunction, comparing the two groups