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

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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