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

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ClinicalTrials.gov Identifier: NCT02480621
Recruitment Status : Completed
First Posted : June 24, 2015
Results First Posted : October 20, 2017
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Roy Davidovitch, M.D., Jamaica Hospital Medical Center

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.

Condition or disease Intervention/treatment Phase
Ankle Fracture Drug: Liposomal Bupivacaine with Bupivacaine Phase 3

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  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Impact of Liposomal Bupivicaine on Post-Operative Pain in Orthopaedic Trauma Surgery: A Double-Blind Prospective Randomized Control Trial
Study Start Date : December 2014
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : August 31, 2016

Resource links provided by the National Library of Medicine


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 Name: Exparel




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480621


Locations
United States, New York
Jamaica Hospital Medical Center
Jamaica, New York, United States, 11418
Sponsors and Collaborators
Jamaica Hospital Medical Center
Investigators
Principal Investigator: Roy Davidovitch, MD Jamaica Hospital Medical Center

Publications:
Responsible Party: Roy Davidovitch, M.D., Assistant Professor of Orthopaedic Surgery, Jamaica Hospital Medical Center
ClinicalTrials.gov Identifier: NCT02480621     History of Changes
Other Study ID Numbers: 623477-4
First Posted: June 24, 2015    Key Record Dates
Results First Posted: October 20, 2017
Last Update Posted: October 20, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Fractures, Bone
Ankle Fractures
Wounds and Injuries
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents