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
Overview
- Phase
- Phase 4
- Intervention
- Liposomal bupivacaine
- Conditions
- Osteoarthritis
- Sponsor
- Albany Medical College
- Locations
- 1
- Primary Endpoint
- Achievement of rehabilitative goals
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Eric Silverman
Director of Regional Anesthesia and Acute Pain Management
Albany Medical College
Eligibility 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)
Arms & Interventions
Liposomal bupivacaine
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.
Intervention: Liposomal bupivacaine
Standard bupivacaine plus dexamethasone
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.
Intervention: Bupivacaine plus dexamethasone
Outcomes
Primary Outcomes
Achievement of rehabilitative goals
Time Frame: Time until discharge (up to 2 weeks)
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).
Secondary Outcomes
- Mean postoperative pain score assessment (24, 48 and 72 hours post-operatively)(Throughout admission (up to 2 weeks))