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

January 22, 2020 updated by: Eric Silverman, Albany Medical College

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Active Comparator: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time until discharge (up to 2 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean postoperative pain score assessment (24, 48 and 72 hours post-operatively)
Time Frame: 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.
Throughout admission (up to 2 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative pain score assessment
Time Frame: 24, 48 and 72 hours postoperatively
Assessment of cumulative pain score reflected by area under the curve (AUC) for NRS scores through 12, 24, 36, 48, 60, and 72 hrs.
24, 48 and 72 hours postoperatively
Mean daily Opioid consumption
Time Frame: 24, 48, 72 hours post-operatively, and until discharge (up to 2 weeks)
Mean daily opioid consumption as morphine equivalents using the online calculator http://www.nyc.gov/html/doh/html/mental/MME.html
24, 48, 72 hours post-operatively, and until discharge (up to 2 weeks)
Mean length of stay in days
Time Frame: Through study completion (up to 2 weeks)
Through study completion (up to 2 weeks)
Time to first use of postsurgical opioid medication
Time Frame: Up to 24 hours postoperatively
Up to 24 hours postoperatively
Proportion of patients receiving no post-surgery rescue opioid medication
Time Frame: 0, 6, 12, 24 and 72 hours postoperatively
0, 6, 12, 24 and 72 hours postoperatively
Discharge to home versus rehabilitation services among the comparison cohorts
Time Frame: Up to hospital discharge (up to 2 weeks)
Up to hospital discharge (up to 2 weeks)
Total cost comparisons between the two cohorts
Time Frame: Up to hospital discharge (up to 2 weeks)
Including medications, nursing care costs, operating room costs, rehabilitation costs
Up to hospital discharge (up to 2 weeks)
Quality of recovery assessment
Time Frame: Postoperatively at day 0, 1, 2 and prior to discharge (up to 2 weeks)
Postoperatively at day 0, 1, 2 and prior to discharge (up to 2 weeks)
Functional outcomes
Time Frame: At 6 weeks, 3 months, 6 months and 1 year postoperatively
Functional outcomes following total knee arthroplasty at 6 weeks, 3 months, 6 months, 1 year using the Knee Society Score.
At 6 weeks, 3 months, 6 months and 1 year postoperatively
Functional outcomes
Time Frame: At 6 weeks, 3 months, 6 months and 1 year postoperatively
Functional outcomes following total knee arthroplasty at 6 weeks, 3 months, 6 months, 1 year using the Lower Extremity Functional Score
At 6 weeks, 3 months, 6 months and 1 year postoperatively
Activity levels
Time Frame: At 6 weeks, 3 months, 6 months and 1 year postoperatively
Activity levels following total knee arthroplasty at 6 weeks, 3 months, 6 months, and 1 year using the University of California Los Angeles scores
At 6 weeks, 3 months, 6 months and 1 year postoperatively
Objective quadriceps strength assessment
Time Frame: At 24 hours postoperatively
Objective quadriceps strength assessment using a Biodex isokinetic dynamometer at 24 hours post-operatively and at the time of discharge
At 24 hours postoperatively
Patient perceived health outcomes
Time Frame: 6 weeks, 3 months, 6 months, and up to 1 year
Patient perceived health outcomes at 6 weeks, 3 months, 6 months, and up to 1 year using Short Form-36 scores
6 weeks, 3 months, 6 months, and up to 1 year
Evaluate and observe any adverse reactions and complications
Time Frame: From time of randomization through study completion (up to 1 year)
From time of randomization through study completion (up to 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albany Medical College

Investigators

  • Principal Investigator: Eric Silverman, MD, Albany Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

December 4, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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