Comparison of Exparel to Bupivacaine With Dexamethasone in TAP Block

• Status: Terminated
• Trial end date: 2015-06-06
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy and duration of bupivacaine extended-release liposome injection (Exparel) versus bupivacaine with dexamethasone in transversus abdominis plane (TAP) blocks for patients undergoing abdominal surgery at Emory University Hospital and Emory University Hospital Midtown.

The investigators hypothesize that Exparel will provide greater postoperative pain relief than bupivacaine with dexamethasone. The investigators plan to enroll up to 50 male and female subjects meeting inclusion and exclusion criteria who will be randomized to receive either Exparel (Group 1) or bupivacaine with epinephrine and dexamethasone (Group 2) in the TAP block to achieve at least 22 subjects in each group

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Colette Curtis MD
• Treatments: Acetaminophen; BB 1101; Bupivacaine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Male and female patients undergoing scheduled abdominal surgery at Emory University Hospital or Emory University Hospital Midtown

• Patients willing and able to provide written informed consent

Exclusion Criteria:

• Patients less than 18 years of age, since Exparel has not been studied in this age group

• Patients who are pregnant or lactating, since Exparel has not been shown to be safe in this population, and because of potential drug transfer to child

• Patients with uncontrolled diabetes since dexamethasone may cause hyperglycemia

• Patients with liver dysfunction, since bupivacaine is hepatically metabolized

• Patients with renal failure, since bupivacaine is renally excreted, defined as requiring hemodialysis or renal replacement therapy

• Patients with allergy to one of the study drugs

• Patients with local infection, which may be exacerbated by dexamethasone

• Patients with significant opioid tolerance, defined as taking at least 60 mg oral morphine per day, 3 mg oral oxycodone per day, 25 mcg/hr fentanyl patch, 25 mg oral oxymorphone per day, 8 mg of oral hydromorphone per day or an equianalgesic dose of another opioid for one week or longer

• Patients with known coagulopathy, since bleeding risk is higher Patients who are getting neuraxial anesthesia for surgery