Comparing Post-Op Narcotic Usage in Patients Receiving Periarticular Exparel vs. Standard Periarticular Joint Inj

Completed · Phase 4

Conditions studied: Arthroplasty, Replacement, Knee

In brief

This study seeks to determine whether a new sustained-release local anesthetic solution (Exparel - Liposomal Bupivacaine) injected into the soft tissues around the joint after surgery will decrease opioid consumption and adverse events in opioid-tolerant patients presenting for total knee arthroplasty. The research hypothesis is that the Exparel (study) group will use less opioid in the first 48 hours post-operatively than the control group.

Key facts

Study ID

NCT02682498

Run by

University of California, Irvine

People needed

38

Starts

2013-10-01

Expected to finish

2015-08-01

Last updated by the study team

2017-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and Females age 18+ years old having total knee arthroplasty at UCI
• Meet at least one of the following criteria "opioid tolerant":
• Taking 50mg oral morphine equivalent or more per day
• On long-acting opioids (fentanyl pathc, oxycontin, methadone, etc.)
• Being followed by a chronic pain physician
• All subjects must be free of renal or hepatic dysfunction; defined as:
• Glomerular filtration rate >60 mL/min/1.73m\^2
• AST \& ALT <150, total bilirubin <1.0, INR <1.3 (if not taking anticoagulants)
• No active hepatitis, no jaundice
• Control group- received standard periarticular injection Research group- receives Exparel injection

You may not qualify if…

• Allergy to local Anesthetic
• Pregnancy
• Nursing mothers
• Children<18 years of age
• Renal impairment (GFR<60 mL/min/1.73 m\^2
• Hepatic impairment (active hepatitis, elevated AST or ALT, jaundice)
• Any history of ventricular arrhythmia or supraventricular tachycardia, or myocardial infarction within the last six months.

Where it is running

• UC Irvine Medical Center — Orange, California, United States

Full record on ClinicalTrials.gov

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