A Comparison of Exparel to Bupivacaine in TAP Block for Abdominal Gynecologic Surgery

The proposed pilot study is evaluating the use of Exparel ™ in an anesthesia protocol for
patients undergoing major lower abdominal gynecologic surgery. Exparel ™ is a formulation of
liposomal bupivicaine that is reputed to have a much longer duration of action compares to
bupivacaine. Exparel™ has been originally demonstrated to be safe and effective in
bunionectomy and hemorrhoidectomy. It has recently gained FDA approval for all surgical site
infiltration including TAP (Transversus Abdominis Planus block) blocks. Exparel™ has also
been studied in other procedures and demonstrated reduction in opioid use and median length
of stay (LOS).

Currently, patients on the gynecologic oncology service undergoing major abdominal surgery
are receiving a type of regional anesthesia using bupivacaine HCl known as a TAP block as
part of an effort to decrease narcotic use post-operatively and decrease hospital length of
stay. Bupivacaine has a known eight to twelve hour duration of action, thus addressing
immediate post operative pain. As Exparel™ is anticipated to have a longer duration of
action, the purpose of this study is to determine if TAP blocks with Exparel™ have an
advantage over standard TAP blocks with bupivacaine HCl in reducing length of hospital stay
in a randomized controlled trial. Our hypothesis is that TAP blocks with Exparel™ will result
in reduced length of stay contributing to significant hospital cost savings. Secondary
outcomes include total narcotic use (hypothesized to be reduced) and overall complication
rates (hypothesized to remain unchanged). Given there are no published data on the efficacy
and safety of using Exparel™ in open gynecologic abdominal surgery, this will be a pilot
study.

Inclusion Criteria:

- all patients undergoing planned exploratory laparotomy

- TAP blocks placed after the laparotomy incision is closed, but before the patient is
awake, and placed under ultrasound guidance with correct identification of the correct
abdominal plane.

- Consent for TAP block signed by patients preoperatively by anesthesiology

Exclusion Criteria:

- All pregnant patients

- All patients under 18 years of age

- minimally invasive surgery such as laparoscopy or robotic assisted laparoscopy

- medical contraindications to use of bupivacaine or liposomal bupivacaine such as
severe hepatic and/or renal disease