Overview

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

Status:
Completed

Trial end date:
2016-08-31

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Jamaica Hospital Medical Center

Treatments:

Bupivacaine

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