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

University of California Irvine (UCI)

Status and phase: Completed; Phase 4

Conditions: Arthroplasty, Replacement, Knee

Treatments: Drug: Standard Preparation; Drug: (Bupivacaine Liposome Injectable Suspension)

Study type: Interventional

Funder types: Other

Identifiers

NCT02682498

UCIANES08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

EXPAREL® Bupivacaine Liposome Suspension

Active Comparator group

Description:

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.

Treatment:

Drug: (Bupivacaine Liposome Injectable Suspension)

Standard periarticular joint injection

Active Comparator group

Description:

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.

Treatment:

Drug: Standard Preparation