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

Primary Purpose

Osteoarthritis, Pain, Postoperative

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
Bupivacaine plus dexamethasone
Sponsored by
Albany Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring primary total knee arthroplasty, liposomal bupivacaine

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Albany Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liposomal bupivacaine

Standard bupivacaine plus dexamethasone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
December 1, 2015
Last Updated
January 22, 2020
Sponsor
Albany Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT02624856
Brief Title
Liposomal Bupivacaine Versus Standard Bupivacaine Plus Dexamethasone in Quadriceps Sparing Femoral Nerve Block and Wound Infiltration for Total Knee Arthroplasty
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Pain, Postoperative
Keywords
primary total knee arthroplasty, liposomal bupivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Silverman, MD
Organizational Affiliation
Albany Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States

12. IPD Sharing Statement

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

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