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

Albany Medical College

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Osteoarthritis Pain, Postoperative

Interventions

Liposomal bupivacaineDRUG

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.

Bupivacaine plus dexamethasoneDRUG

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Albany Medical Center

Albany, New York, United States

Outcomes

Primary Outcomes

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 frame: Time until discharge (up to 2 weeks)

Secondary Outcomes

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.

Time frame: Throughout admission (up to 2 weeks)

Data from ClinicalTrials.gov

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