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

NCT02624856 | Withdrawn Phase 4

• 1 other identifier: 4059
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

primary total knee arthroplasty; liposomal bupivacaine

Outcome Measures

Primary Outcomes (1)

• Achievement of rehabilitative goals

  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).

  Time until discharge (up to 2 weeks)

Secondary Outcomes (1)

• Mean postoperative pain score assessment (24, 48 and 72 hours post-operatively)

  Throughout admission (up to 2 weeks)

Other Outcomes (14)

• Cumulative pain score assessment

  24, 48 and 72 hours postoperatively

• Mean daily Opioid consumption

  24, 48, 72 hours post-operatively, and until discharge (up to 2 weeks)

• Mean length of stay in days

  Through study completion (up to 2 weeks)

Study Arms (2)

Liposomal bupivacaine

EXPERIMENTAL

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.

Drug: Liposomal bupivacaine

Standard bupivacaine plus dexamethasone

ACTIVE COMPARATOR

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.

Drug: Bupivacaine plus dexamethasone

Interventions

Liposomal bupivacaine 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.

Liposomal bupivacaine

Bupivacaine plus dexamethasone 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

Standard bupivacaine plus dexamethasone

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

Location

Related Publications (38)

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MeSH Terms

Conditions

Osteoarthritis; Pain, Postoperative

Interventions

Bupivacaine; Dexamethasone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Eric Silverman, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Regional Anesthesia and Acute Pain Management

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 9, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: January 1, 2020
• Last Updated: January 23, 2020

Record last verified: 2016-08

Locations

US (1)