drugset / Trial / NCT02072135

Exparel and Ankle Surgery

NCT02072135 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2014-02
Primary completion
2015-11
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 266 mg Other

Indications

No indication recorded.