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

• Status: Withdrawn
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albany Medical College
• Treatments: BB 1101; Bupivacaine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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.