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

Completed · Phase 3

Conditions studied: Ankle Fracture

In brief

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.

Key facts

Study ID

NCT02480621

Run by

Jamaica Hospital Medical Center

People needed

84

Starts

2014-12-01

Expected to finish

2016-08-31

Last updated by the study team

2017-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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