Clinical trial NCT02682498: Comparing Post-Op Narcotic Usage in Patients Receiving Periarticular Exparel vs. Standard Periarticular Joint Inj
Official title: A Double Blind, Randomized Clinical Trial Comparing Postoperative Narcotic Usage in Patients Receiving Periarticular Liposomal Bupivicaine vs. Those Patients Receiving Standard Periarticular Joint Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthroplasty, Replacement, Knee
Keywords: Knee Arthroplasty, Total
Liposomal Bupivicaine
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2016-02-15
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: 48 Hour Post-surgical Opioid Use
timeFrame: 48 hours
Secondary outcomes:
measure: Recovery Room Opioid Use
timeFrame: Up to 48 hours
measure: Average Daily Opioid Use During Admission
timeFrame: Up to 48 hours
measure: Average Daily Patient Pain Score
timeFrame: Up to 48 hours
measure: Post-operative Complications
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Joseph Rinehart, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huxtable CA, Roberts LJ, Somogyi AA, MacIntyre PE. Acute pain management in opioid-tolerant patients: a growing challenge. Anaesth Intensive Care. 2011 Sep;39(5):804-23. doi: 10.1177/0310057X1103900505.
citation: Zywiel MG, Stroh DA, Lee SY, Bonutti PM, Mont MA. Chronic opioid use prior to total knee arthroplasty. J Bone Joint Surg Am. 2011 Nov 2;93(21):1988-93. doi: 10.2106/JBJS.J.01473.
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citation: Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. 2012;5:107-16. doi: 10.2147/JPR.S30861. Epub 2012 May 1.
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