Efficacy of Extended-Release Liposomal Bupivacaine for Post-Partum Pain Management Following Obstetrical Laceration
Status:
Completed
Trial end date:
2019-03-01
Target enrollment:
Participant gender:
Summary
We propose a prospective, randomized, single blinded trial with subjects recruited from the
WRNMMC Labor and Delivery Unit to study post-partum efficacy of Exparel® for pain control in
patients undergoing a vaginal delivery who sustained a second, third, or fourth degree
obstetrical laceration. Subjects who meet inclusion criteria and agree to participate in the
study will be consented upon admission for active labor or induction of labor and will be
randomized to receive either 20mL of liposomal bupivacaine or 20ml of 0.25% plain
bupivacaine, infiltrated through the perineum at completion of their obstetrical repair.
Current standard of care is to receive no injection of local anesthetic upon completion of
the repair.
The primary aim of the trial will be to evaluate post-partum pain using a visual analogue
pain scale at days 1, 3 and 7 postpartum. 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 post-partum pain control regimen.
We anticipate a 30% difference in post-operative pain measurements between the Exparel® group
and the plain bupivacaine group. Other aims of this study are to evaluate total medication
usage, comparing the study group to the control, and compare quality of life measures between
the two study groups.