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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Drug: (Bupivacaine Liposome Injectable Suspension)
* Drug: Standard Preparation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EXPAREL® Bupivacaine Liposome Suspension<br>Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours. | Drug: (Bupivacaine Liposome Injectable Suspension)<br>* Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery.<br>* Other names: EXPAREL®;|
| Active Comparator: Standard periarticular joint injection<br>A standard joint injection of 100ml (Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml) will be injected into the soft tissues around the joint after surgery. | Drug: Standard Preparation<br>* A standard joint injection of 100ml (Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml) will be injected into the soft tissues around the joint after surgery.<br>* Other names: Standard Periarticular Joint Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 48 Hour Post-surgical Opioid Use | A comparison of group means between the control group and study group with regards to 48 hour opioid use. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery Room Opioid Use | Post anesthesia care unit (recovery room) opioid use in total mg morphine IV equivalent in comparison of standard knee injection post-operatively. | Up to 48 hours | 
| Average Daily Opioid Use During Admission | Opioid use will be monitored daily from the time of admission in comparison of standard knee injection post-operatively. | Up to 48 hours | 
| Average Daily Patient Pain Score | Examining the average daily patient pain score in comparison of standard knee injection post-operatively. The measure is the Visual-Analog-Scale (VAS) for subjective pain reporting. The minimum 0 (no pain) and the maximum is 10 (worst pain imagineable). There is only one measure in the scale (i.e. there are no subscales). Lower scores on the VAS scale equate to less pain and are therefore desirable. | Up to 48 hours | 
| Post-operative Complications | Examining the post-operative complication in comparison of standard knee injection post-operatively. | Up to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Arthroplasty, Total, Liposomal Bupivicaine