Overview

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

Status:
Completed
Trial end date:
2015-08-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of California, Irvine
Treatments:
Bupivacaine
Narcotics
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.