- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01853176
Exparel vs. Standard Bupivicaine for Abdominoplasty
Is Liposomal Injection Bupivacaine (Exparel) Superior to Standard Bupivacaine for Abdominoplasty? A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital
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Atlanta, Georgia, United States, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, United States, 30327
- Emory Aesthetic Center at Paces
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- adult men and women
- scheduled for abdominoplasty
Exclusion Criteria:
- pregnant women
- patients with allergy to amide-type local anesthetics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Liposomal injection bupivicaine (Exparel)
Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.
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Other Names:
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Active Comparator: Standard bupivicaine
Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg.
150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Score, Visual Analogue Pain Scores
Time Frame: 3 days
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Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain.
Patients will complete a log of pain levels experienced each morning and evening for 3 days.
Score is 0-10 on a visual analog scale.
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3 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Albert Losken, MD, Emory University
Publications and helpful links
General 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.
- 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.
- 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. doi: 10.1177/000313481207800540.
- 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):1723-1732. doi: 10.1097/PRS.0b013e3181ef8fe5.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00064693
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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