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

NCT ID: NCT02480621

Last Updated: 2017-10-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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This study is a prospective, 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. Patients are to remain blinded to the treatment arm. The surgeon is non-blinded and administers the bupivacaine solution locally, intra-operatively.

Patients pain scores and pain medication usage is documented. A trained research coordinator contacts each patient at 24, 48, and 72 hours post-operatively to assess pain levels on a visual analog scale (VAS) and pain medications taken. Patients return for followup at standard intervals of 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post-operatively to assess healing and functional outcomes. Patients are queried as to satisfaction with pain control at 2 weeks post-operatively. The study will compare outcomes including pain levels, pain medications taken, operating room (OR) and post-anesthesia care unit (PACU) times, length of stay (LOS), satisfaction with pain control, clinical outcomes, and complication rates.

Conditions

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Ankle Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Liposomal Bupivacaine with Bupivacaine

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

Group Type EXPERIMENTAL

Liposomal Bupivacaine with Bupivacaine

Intervention Type DRUG

Pain medications injected locally during surgery around affected ankle.

Interventions

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Liposomal Bupivacaine with Bupivacaine

Pain medications injected locally during surgery around affected ankle.

Intervention Type DRUG

Other Intervention Names

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Exparel

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Patients younger than 18 years old
2. Patients who are on chronic opioids
3. Patients who abuse opioids
4. Patients who are unwilling to follow-up for a minimum of 52 weeks
5. Neurologic condition that could interfere with pain sensation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jamaica Hospital Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Roy Davidovitch, M.D.

Assistant Professor of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roy Davidovitch, MD

Role: PRINCIPAL_INVESTIGATOR

Jamaica Hospital Medical Center

Locations

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Jamaica Hospital Medical Center

Jamaica, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23977664 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25830260 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25750943 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25614060 (View on PubMed)

Other Identifiers

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623477-4

Identifier Type: -

Identifier Source: org_study_id