Comparison of Exparel to Bupivacaine With Dexamethasone in TAP Block
Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Bupivacaine Extended-Release Liposome Injection (Exparel) (Drug); Bupivacaine and Dexamethasone Injection (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Colette Curtis MD Official(s) and/or principal investigator(s): Colette Curtis, MD, Principal Investigator, Affiliation: Emory University
Overall contact: Colette Curtis, MD, Phone: 404-778-3900, Email: ccurti3@emory.edu
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
Clinical Details
Official title: Comparison Between Bupivacaine Extended-Release Liposome Injection (Exparel) Versus Bupivacaine With Dexamethasone in Transversus Abdominis Plane Block: A Prospective Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Total amount of opioid consumption at 72 hours after surgery
Secondary outcome: Visual Analogue Scale(VAS) Pain Score at restVisual Analogue Scale (VAS) pain score with movement Time of first opioid use after surgical procedure
Detailed description:
Group 1 will be administered 266 mg of Exparel, diluted to 30 mL. Group 2 will be given 28
mL of 0. 375% bupivacaine and 8mg/2 mL dexamethasone. Before injection of the study
medication, 2mL of normal saline with be injected under ultrasound visualization to ensure
needle tip is in the transversus abdominis plane. Randomization will occur following the
written informed consent and prior to the start of the surgical procedure. Postoperatively,
study patients will receive intravenous acetaminophen 1000mg every 8 hours for 3 doses, then
oral acetaminophen 650mg every 6 hours. Subjects will also have patient-controlled analgesia
(PCA) with morphine or hydromorphone. The research staff recording data will be blinded to
the treatment group. Demographic data will be recorded, including age, date of birth, height
and weight to ensure similarity between the two groups. A medical history will be obtained
as well as surgical and anesthesia details. Study patients will be followed for 72 hours
postoperatively to record the amount of opioid consumption, as well as other pain score data
using the Visual Analogue Scale (VAS).The subject's participation will end 72 hours after
surgery. A telephone interview will occur with the subject if hospital discharge occurs
prior to 72 hours.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Colette Curtis, MD, Phone: 404-778-3900, Email: ccurti3@emory.edu
Emory University Hospital, Atlanta, Georgia 30322, United States; Recruiting Colette Curtis, MD, Email: ccurti3@emory.edu Kathy Egan, RN, Phone: 404-727-8463, Email: kfegan@emory.edu Colette Curtis, MD, Principal Investigator Elizabeth S Faucher, MD, Sub-Investigator
Emory University Hospital Midtown, Atlanta, Georgia 30308, United States; Recruiting Colette Curtis, MD, Principal Investigator Elizabeth Faucher, MD, Sub-Investigator
Additional Information
Starting date: July 2014
Last updated: March 31, 2015
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