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:

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