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

September 19, 2017 updated by: Roy Davidovitch, M.D., Jamaica Hospital Medical Center

The Impact of Liposomal Bupivicaine on Post-Operative Pain in Orthopaedic Trauma Surgery: A Double-Blind Prospective Randomized Control Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Jamaica, New York, United States, 11418
        • Jamaica Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
No Intervention: Control
Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle.
Experimental: Liposomal Bupivacaine with Bupivacaine
Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle.
Drug: Liposomal Bupivacaine with Bupivacaine
Pain medications injected locally during surgery around affected ankle.
Other Names:
  • Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Levels on a Visual Analog Scale ( VAS)
Time Frame: Immediate post-operative period until 72 hours post-operatively
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jamaica Hospital Medical Center

Investigators

  • Principal Investigator: Roy Davidovitch, MD, Jamaica Hospital Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

June 30, 2016

Study Completion (Actual)

August 31, 2016

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Actual)

October 20, 2017

Last Update Submitted That Met QC Criteria

September 19, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 623477-4

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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