Liposomal Bupivacaine Versus Standard Bupivacaine Plus Dexamethasone in Quadriceps Sparing Femoral Nerve Block and Wound Infiltration for Total Knee Arthroplasty

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and duration of pain relief after total knee arthroplasty provided by a single injection of liposomal bupivacaine (EXPAREL®) versus standard bupivacaine with an adjuvant, dexamethasone when administered as a quadriceps sparing femoral nerve block and periarticular injection. It is hypothesized that liposomal bupivacaine is superior to standard bupivacaine with dexamethasone and will decrease time to discharge readiness.

Official Title
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Prospective, Randomized, Double-Blinded, Allocation Concealed Study Comparing the Efficacy of Liposomal Bupivacaine Over Standard Bupivacaine Plus Dexamethasone in Quadriceps Sparing Femoral Nerve Block and Wound Infiltration for Primary Total Knee Arthroplasty

Conditions
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Osteoarthritis, Pain, Postoperative

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: Bupivacaine plus dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients of American Society of Anesthesiologist (ASA) I-III physical class with a pre-operative diagnosis of primary osteoarthritis scheduled for elective primary total knee arthroplasty. Patients must be living independently at home prior to undergoing primary total knee arthroplasty with intention of discharge directly to home after hospitalization Exclusion Criteria: Subjects will not be eligible for this trial if they have a history of allergy to a local anesthetic Known peripheral neuropathy Known connective tissue or immunological disorders Stroke or other known central nervous system disorders Renal dysfunction Hepatic dysfunction Cardiac dysfunction other than hypertension Pregnant subjects Immunosuppression Human immunodeficiency virus (HIV) Alcohol or drug abuse Chronic pain or opioid dependence Coagulopathy or those unable to comply with study requirements.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal bupivacaine<br>Liposomal bupivacaine (EXPAREL®) 133 mg in 10 mL for quadriceps sparing femoral nerve block and 133 mg in 20 mL for posterior knee compartment periarticular injection. | Drug: Liposomal bupivacaine<br>* Liposomal bupivacaine (EXPAREL®) 133 mg in 10 mL for quadriceps sparing femoral nerve block and 133 mg in 20 mL for posterior knee compartment periarticular injection.<br>|
| Active Comparator: Standard bupivacaine plus dexamethasone<br>Bupivacaine 0.5% 10 mL plus 2 mg dexamethasone for quadriceps sparing femoral nerve block and bupivacaine 0.25% 20 mL plus 2 mg of dexamethasone for posterior knee compartment periarticular injection. | Drug: Bupivacaine plus dexamethasone<br>* Bupivacaine HCl 0.5% 10 mL plus dexamethasone 2 mg for quadriceps sparing femoral nerve block and bupivacaine HCl 0.25% plus dexamethasone 2 mg for posterior knee compartment periarticular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of rehabilitative goals | Assessment of temporal achievement of rehabilitative goals for discharge (independent ambulation to 100 feet, stair climbing, timed-up-and-go, independent toileting, ability to get dressed independently, capacity to get in and out of bed, capability to sit and rise from a chair/toilet, independence in personal care, mobilization with walker/crutches, and NRS<5 on activity). | Time until discharge (up to 2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean postoperative pain score assessment (24, 48 and 72 hours post-operatively) | Assessment of mean post-operative pain using a Numeric rating scale (NRS)- both at rest and during active knee flexion to 45 degree at 24, 48 and 72 hours post-operatively. | Throughout admission (up to 2 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary total knee arthroplasty, liposomal bupivacaine