Exparel vs. Standard Bupivicaine for Abdominoplasty
Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative
Intervention: Liposomal Injection Bupivacaine (Exparel) (Drug); Standard bupivicaine (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Emory University Official(s) and/or principal investigator(s):
Albert Losken, MD, Principal Investigator, Affiliation: Emory University
Summary
Background & study question:
Strategies for post-operative pain control that make use of various different types of
medicines are advantageous both for patient comfort and for minimizing the use of opioid
pain medicines and their associated side effects, which include drowsiness, nausea, and
vomiting. A key element of these strategies is wound injection with local anesthetic
(numbing medicine) at the time of surgery. Local numbing procedures are used routinely in
patients undergoing abdominoplasty (tummy tuck), most often with lidocaine or bupivacaine,
which can last several hours. Multiple studies have shown that locally injected pain
medicines achieve better pain control, less opioid use, and faster return to normal
activities, such that the use of one of these local anesthetic medicines is the current
standard of care.
Exparel is an extended-release formulation of bupivacaine that can produce local pain relief
for up to 72 hours. Studies have shown it to provide better post-operative pain control and
decreased use of opioid medications when compared to patients who did not receive any local
numbing agents. Exparel has been used successfully in a variety of surgical settings,
including open colon surgery, laparoscopic gall bladder removal, abdominoplasty, and breast
augmentation. Its effectiveness has by and large been established in comparison to no local
anesthetic. In this study, we seek to investigate the benefit of Exparel compared to
standard bupivacaine infiltration in patients undergoing abdominoplasty.
Study design:
Patients scheduled for abdominoplasty with the lead investigator will be offered inclusion
in this study. Consenting patients will be randomly assigned to standard bupivacaine or
Exparel by coin toss after their clinic visit. On the day of surgery, the only difference
between patients assigned to one arm or the other is the local anesthetic used. The surgery
itself and plan for general anesthesia will be similar. Both groups will have the same pain
medicines available after surgery.
Patients will be given a form on which to record twice-daily pain ratings and opioid
narcotic needs for 3 days after surgery. For patients admitted after surgery, oral and IV
narcotic use will be collected from their inpatient medical record.
The primary outcome of interest is daily and cumulative pain scores through 3 days. A
secondary endpoint is daily and total opioid use over 3 days. Additional measures include
the time to first post-operative use of opioid medication and incidence of any adverse side
effects.
Clinical Details
Official title: Is Liposomal Injection Bupivacaine (Exparel) Superior to Standard Bupivacaine for Abdominoplasty? A Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Pain Score, Visual Analogue Pain Scores
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- adult men and women
- scheduled for abdominoplasty
Exclusion Criteria:
- pregnant women
- patients with allergy to amide-type local anesthetics
Locations and Contacts
Emory Aesthetic Center at Paces, Atlanta, Georgia 30327, United States
Emory University Hospital, Atlanta, Georgia 30322, United States
Emory University Hospital Midtown, Atlanta, Georgia 30308, United States
Additional Information
Related publications: Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1. Haas E, Onel E, Miller H, Ragupathi M, White PF. A double-blind, randomized, active-controlled study for post-hemorrhoidectomy pain management with liposome bupivacaine, a novel local analgesic formulation. Am Surg. 2012 May;78(5):574-81. Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3. Chavez-Abraham V, Barr JS, Zwiebel PC. The efficacy of a lidocaine-infused pain pump for postoperative analgesia following elective augmentation mammaplasty or abdominoplasty. Aesthetic Plast Surg. 2011 Aug;35(4):463-9. doi: 10.1007/s00266-010-9633-4. Epub 2010 Dec 7. Feng LJ. Painless abdominoplasty: the efficacy of combined intercostal and pararectus blocks in reducing postoperative pain and recovery time. Plast Reconstr Surg. 2010 Nov;126(5):1723-32. doi: 10.1097/PRS.0b013e3181ef8fe5.
Starting date: May 2013
Last updated: October 29, 2014
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