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

A Pilot Study: A Comparison of Liposomal Bupivacaine to Bupivacaine HCl in Transversus Abdominis Planus Block for Abdominal Gynecologic Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Gynecologic Cancer; Post Operative Pain
• Intervention / Treatment: Drug: Bupivacaine; Drug: liposomal bupivacaine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Heidi Ching, MD; Phone Number: 215-481-4231; Email: heidi.ching@jefferson.edu
• Study Contact Backup: Name: Mark Shahin, MD; Phone Number: 215-885-0220; Email: mark.shahin@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Recruiting
      • Abington Hospital Jefferson Health
      • Contact: Mark Shahin, MD; Phone Number: 215-885-0220; Email: mark.shahin@jefferson.edu
      • Contact: Heidi Ching, MD; Phone Number: 215-481-4211; Email: heidi.ching@jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacaine HCl in TAP block; 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.	Drug: Bupivacaine; bupivacaine hydrochloride used in TAP block
Experimental: Liposomal Bupivicaine in TAP block; 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.	Drug: liposomal bupivacaine; liposomal bupivacaine used in TAP block; Other Names: Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay post operatively in hospital	number of hours patient stays post operatively in hospital	through study completion, expected to be approximately 1 year in total

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total opioid use post operatively in hospital	total opioid use in morphine equivalent that patient uses	through study completion, expected to be approximately 1 year in total

Collaborators and Investigators

• Sponsor: Abington Memorial Hospital
• Investigators: Principal Investigator: Heidi Ching, MD, OB GYN Resident

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: September 13, 2016
• First Submitted That Met QC Criteria: October 3, 2017
• First Posted (Actual): October 9, 2017

Study Record Updates

• Last Update Posted (Actual): October 9, 2017
• Last Update Submitted That Met QC Criteria: October 3, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: FWA00004123