Gynecologic Cancer, Post Operative Pain
Conditions
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.
Interventions
DRUGBupivacaine
bupivacaine hydrochloride used in TAP block
DRUGliposomal bupivacaine
liposomal bupivacaine used in TAP block
Sponsors
Abington Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay post operatively in hospital | through study completion, expected to be approximately 1 year in total | number of hours patient stays post operatively in hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total opioid use post operatively in hospital | through study completion, expected to be approximately 1 year in total | total opioid use in morphine equivalent that patient uses |
Countries
United States
Contacts
Primary ContactHeidi Ching, MD
Backup ContactMark Shahin, MD
Outcome results
None listed