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

NCT ID: NCT02624856

Last Updated: 2020-01-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2020-01-01

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.

Conditions

Osteoarthritis; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Liposomal bupivacaine

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Bupivacaine plus dexamethasone

Intervention Type: DRUG

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

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 Type: DRUG

Bupivacaine plus dexamethasone

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

Intervention Type: DRUG

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)
• Alcohol or drug abuse
• Chronic pain or opioid dependence
• Coagulopathy or those unable to comply with study requirements.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albany Medical College

OTHER

Sponsor Role: lead

Responsible Party

Eric Silverman

Director of Regional Anesthesia and Acute Pain Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Silverman, MD

Role: PRINCIPAL_INVESTIGATOR

Albany Medical College

Locations

Albany Medical Center

Albany, New York, United States

Countries

United States

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Other Identifiers

4059

Identifier Type: -

Identifier Source: org_study_id