Liposomal Bupivacaine With Bupivacaine in Ankle Fracture Open Reduction Internal Fixation (ORIF)

NCT02480621 | Completed Phase 3 Results DMC

• 1 other identifier: 623477-4
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled trial assessing pain control in ankle fractures repaired with open reduction and internal fixation. Patients are consented and enrolled pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine administered intra-operatively.

Conditions

Ankle Fracture

Outcome Measures

Primary Outcomes (1)

• Pain Levels on a Visual Analog Scale ( VAS)

  A Visual Analog Scale (VAS) ranging from 0 to 10 in increments of 1 was used to both qualitatively and quantitatively assess the level and severity of pain during the time points ranging from the immediate post-operative period through 72 hours post-operative. Each number on the scale is accompanied by a visual facial expression that indicates the level of pain, discomfort, and distress appropriate to the number on the scale. The more severe the level of pain, the higher the corresponding number and more distressing the accompanying facial expression. A VAS score of 0 indicates no active pain level and is accompanied by a pleasantly smiling face whereas a VAS score of 10 indicates the most severe active pain level and is accompanied by a visibly-distraught face that is frowning, grimacing, and sweating. The combination of facial expressions and numbers is supposed to provide a language-independent, validated means of assessing pain levels.

  Immediate post-operative period until 72 hours post-operatively

Study Arms (2)

Control

NO INTERVENTION

Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle.

Liposomal Bupivacaine with Bupivacaine

EXPERIMENTAL

Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle.

Drug: Liposomal Bupivacaine with Bupivacaine

Interventions

Liposomal Bupivacaine with Bupivacaine DRUG

Pain medications injected locally during surgery around affected ankle.

Also known as: Exparel

Liposomal Bupivacaine with Bupivacaine

Eligibility Criteria

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

You may qualify if:

• Patients at least 18 years old.
• Male or Female
• All racial and ethnic groups
• Fractures and fracture/dislocations of the ankle
• Patients who opt for surgical treatment of their fractures.
• Patients who consent to be randomized.
• Patients who are willing to follow-up for a minimum of 52 weeks.

You may not qualify if:

• Patients younger than 18 years old
• Patients who are on chronic opioids
• Patients who abuse opioids
• Patients who are unwilling to follow-up for a minimum of 52 weeks
• Neurologic condition that could interfere with pain sensation

Sponsors & Collaborators

• Jamaica Hospital Medical Center: lead

Study Sites (1)

Jamaica Hospital Medical Center

Jamaica, New York, 11418, United States

Location

Related Publications (4)

• Owen RT. Bupivacaine liposome injectable suspension: a new approach to postsurgical pain. Drugs Today (Barc). 2013 Aug;49(8):475-82. doi: 10.1358/dot.2013.49.8.2006992.

  PMID: 23977664 BACKGROUND

• Joshi GP, Cushner FD, Barrington JW, Lombardi AV Jr, Long WJ, Springer BD, Stulberg BN. Techniques for periarticular infiltration with liposomal bupivacaine for the management of pain after hip and knee arthroplasty: a consensus recommendation. J Surg Orthop Adv. 2015 Spring;24(1):27-35.

  PMID: 25830260 BACKGROUND

• Lonner JH, Scuderi GR, Lieberman JR. Potential utility of liposome bupivacaine in orthopedic surgery. Am J Orthop (Belle Mead NJ). 2015 Mar;44(3):111-7.

  PMID: 25750943 BACKGROUND

• Robbins J, Green CL, Parekh SG. Liposomal bupivacaine in forefoot surgery. Foot Ankle Int. 2015 May;36(5):503-7. doi: 10.1177/1071100714568664. Epub 2015 Jan 22.

  PMID: 25614060 BACKGROUND

MeSH Terms

Conditions

Ankle Fractures

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Adam Driesman
• Organization: Department of Orthopaedic Surgery, NYU Langone Orthopaedic Hospital

Adam.Driesman@nyumc.org

2033315938

Study Officials

• Roy Davidovitch, MD

  Jamaica Hospital Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 24, 2015
• Study Start: December 1, 2014
• Primary Completion: June 30, 2016
• Study Completion: August 31, 2016
• Last Updated: October 20, 2017
• Results First Posted: October 20, 2017

Record last verified: 2017-09

Locations

US (1)