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

Albany Medical College

Status and phase: Withdrawn; Phase 4

Conditions: Osteoarthritis; Pain, Postoperative

Treatments: Drug: Liposomal bupivacaine; Drug: Bupivacaine plus dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02624856

4059

Details and patient eligibility

About

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.

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Liposomal bupivacaine

Experimental group

Description:

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.

Treatment:

Drug: Liposomal bupivacaine

Standard bupivacaine plus dexamethasone

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine plus dexamethasone