Expired Study
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Jamaica, New York 11418


Purpose:

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 summary:

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.


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


NCT ID:

NCT02480621


Primary Contact:

Principal Investigator
Roy Davidovitch, MD
Jamaica Hospital Medical Center


Backup Contact:

N/A


Location Contact:

Jamaica, New York 11418
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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