Clinical trial NCT03304444: A Comparison of Exparel to Bupivacaine in TAP Block for Abdominal Gynecologic Surgery
Official title: A Pilot Study: A Comparison of Liposomal Bupivacaine to Bupivacaine HCl in Transversus Abdominis Planus Block for Abdominal Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gynecologic Cancer
Post Operative Pain
Lead sponsor: Abington Memorial Hospital
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the comparison between liposomal bupivacaine versus bupivacaine HCl in Transversus Abdominis Plane blocks for gynecologic surgery on the length of stay in the hospital, total narcotic use, and overall complications rates.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of stay post operatively in hospital
timeFrame: through study completion, expected to be approximately 1 year in total
Secondary outcomes:
measure: total opioid use post operatively in hospital
timeFrame: through study completion, expected to be approximately 1 year in total
Other outcomes:
Locations:
city: Abington
country: United States
facility: Abington Hospital Jefferson Health
state: Pennsylvania
Study officials:
affiliation: OB GYN Resident
name: Heidi Ching, MD
role: PRINCIPAL_INVESTIGATOR
References: