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

Phase 4

Withdrawn

• Conditions: Pain, Postoperative; Osteoarthritis
• Interventions: Drug: Bupivacaine plus dexamethasone; Drug: Liposomal bupivacaine

• Registration Number: NCT02624856
• Lead Sponsor: Albany Medical College

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2015-12-04
• Study First Posted: 2015-12-09
• Status Verified: 2016-08
• Primary Completion: 2017-11
• Study Completion: 2020-01-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard bupivacaine plus dexamethasone	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.
Liposomal bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
Achievement of rehabilitative goals	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 Outcome Measures

Name	Time	Method
Mean postoperative pain score assessment (24, 48 and 72 hours post-operatively)	Throughout admission (up to 2 weeks)	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.

Trial Locations

Locations (1)

Albany Medical Center; 🇺🇸 Albany, New York, United States