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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03304444
• Other study ID #: FWA00004123
• Status: Recruiting
• Phase: Phase 3
• First received: September 13, 2016
• Last updated: October 3, 2017
• Start date: August 2016
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: Abington Memorial Hospital
• Contact: Heidi Ching, MD
• Phone: 215-481-4231
• Email: heidi.ching[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer
• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Bupivacaine
bupivacaine hydrochloride used in TAP block
• liposomal bupivacaine
liposomal bupivacaine used in TAP block

Locations

Country	Name	City	State
United States	Abington Hospital Jefferson Health	Abington	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abington Memorial Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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