Exparel vs. Standard Bupivicaine for Abdominoplasty

NCT01853176 | Terminated Phase 4 Results

• 1 other identifier: IRB00064693
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Pain, Postoperative

Keywords

Pain, Postoperative; Analgesia; Anesthesia, local; Abdominoplasty

Outcome Measures

Primary Outcomes (1)

• Pain Score, Visual Analogue Pain Scores

  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.

  3 days

Study Arms (2)

Liposomal injection bupivicaine (Exparel)

EXPERIMENTAL

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.

Drug: Liposomal Injection Bupivacaine (Exparel)

Standard bupivicaine

ACTIVE COMPARATOR

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.

Drug: Standard bupivicaine

Interventions

Liposomal Injection Bupivacaine (Exparel) DRUG

Also known as: Exparel, bupivicaine liposome injectable suspension

Liposomal injection bupivicaine (Exparel)

Standard bupivicaine DRUG

Also known as: bupivicaine, Marcaine

Standard bupivicaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult men and women
• scheduled for abdominoplasty

You may not qualify if:

• pregnant women
• patients with allergy to amide-type local anesthetics

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Emory Aesthetic Center at Paces

Atlanta, Georgia, 30327, United States

Location

Related Publications (5)

• 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.

  PMID: 22067185 BACKGROUND

• 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.

  PMID: 22546131 BACKGROUND

• 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.

  PMID: 22900785 BACKGROUND

• 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.

  PMID: 21136251 BACKGROUND

• 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.

  PMID: 21042130 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Trial terminated prior to any meaningful patient accrual so no analysis performed.

Results Point of Contact

• Title: Albert Losken MD
• Organization: Emory University

alosken@emory.edu

404-686-8143

Study Officials

• Albert Losken, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division of Plastic Surgery

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 14, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 3, 2014
• Results First Posted: November 3, 2014

Record last verified: 2014-10

Locations

US (3)