Exparel and Ankle Surgery

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study involves a drug called Exparel that has been approved by the US Food and Drug Administration (FDA), for application directly to wound sites. EXPAREL® is a long acting pain reliever. It is being given in this study to see if it provides safe and effective pain relief after ankle surgery. Because it is a long acting drug, it may lessen pain relief for as much as 72 hours after surgery.

EXPAREL® has not been approved by the FDA for administration by popliteal block, which is the method the study doctors will use to give the patients the drug. Giving the drug by popliteal block involves inserting a small tube in to the back of the knee to deliver the drug. The study doctors wish to determine if patients undergoing ankle surgery and receiving this drug have less pain and less need for narcotic medication.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• ankle fracture open reduction or internal fixation

• American Society of Anesthesiologists rating of I-III

• have a working telephone

Exclusion Criteria:

• non English speaking

• BMI >40

• allergy or contraindication to local anesthetics

• history of drug abuse

• impaired kidney function, rheumatoid arthritis or loss of sensation in extremities

• abnormal liver function

• long term (greater than 10 days) use of NSAIDS

• uncontrolled anxiety, psychiatric or neurological disorder that might interfere with study assessments