Comparison of Exparel to Bupivacaine With Dexamethasone in TAP Block
Condition: Pain
Intervention: Bupivacaine Extended-Release Liposome Injection (Exparel); Bupivacaine and Dexamethasone Injection; IV Acetaminophen; Oral Acetaminophen
Intervention description: 266mg/30mL of Exparel will be injected via unilateral TAP block; As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone will be injected via unilateral TAP block.; Intravenous (IV) acetaminophen 1000 mg every 8 hours for 8 doses.; Oral acetaminophen 650 mg every 6 hours.
Intervention MeSH terms: Acetaminophen; Dexamethasone; Dexamethasone acetate; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anesthesia; surgery; pain

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
    

Eligibility 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