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

Abington Memorial Hospital

Status and phase: Unknown; Phase 3

Conditions: Gynecologic Cancer; Post Operative Pain

Treatments: Drug: Bupivacaine; Drug: liposomal bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03304444

FWA00004123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 2 patient groups

Bupivacaine HCl in TAP block

Active Comparator group

Description:

When performing a bilateral TAP with Bupivicaine 0.25% and the incision is below the umbilicus: 30 ml of 0.25% bupivacaine is drawn up and given on each side after identification of planes by the anesthesiologist (need 2 vials). When performing a bilateral TAP with Bupivicaine 0.25% and the incision extends above the umbilicus: 30 ml of 0.25% bupivacaine is drawn up and given on each side after identification of planes by the anesthesiologist (need 2 vials). A 3rd vial of 30 ml 0.25% bupivacaine will be drawn up and is directly infiltrated into the surgical site (above and below the fascia prior to closure of fascia) extending above the umbilicus by the surgeon.

Treatment:

Drug: Bupivacaine

Liposomal Bupivicaine in TAP block

Experimental group

Description:

When performing a bilateral TAP with liposomal bupivacaine and the incision is below the umbilicus: the 20 ml vial of liposomal bupivacaine containing 266 mg, will be diluted with 20 ml of 0.25% bupivacaine (containing 50 mg of bupivacaine) and 20 ml saline (60 ml total). That total volume will be divided into two 30 ml syringes, and each will be used (per side) for the TAP blocks.

Treatment:

Drug: liposomal bupivacaine