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



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2013
End Date:August 2015

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A Double Blind, Randomized Clinical Trial Comparing Postoperative Narcotic Usage in Patients Receiving Periarticular Liposomal Bupivicaine vs. Those Patients Receiving Standard Periarticular Joint Injections

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.

Opioids have been prescribed with increasing frequency for non-acute, non-cancer pain in the
last 15 years. Because of this, opioid tolerance in the general population has grown
markedly, and opioid tolerant patients can be especially difficult to manage in the
perioperative period. In general, they require much higher doses of opioids to obtain
similar levels of pain-control compared to opioid-naïve patients and are susceptible to
respiratory depression and other adverse events. 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.

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.
We found this trial at
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Orange, California 92868
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Orange, CA
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