Back to resultsExparel vs Exparel Plus ACB in TKAs
Primary Purpose
Knee Osteoarthritis
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
Ropivacaine
Epinephrine
Clonidine
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Male or female, aged 18 to 80 years at the time of surgery.
- Willing and able to give voluntary informed consent to participate in this investigation.
- Candidate for total knee arthroplasty.
- BMI < 35.
Exclusion Criteria:
- Subject has had previous arthroplasty or fracture procedure(s) on the operative knee.
- Creatine level ≥ 1.5
- Pre-existing gait disturbance or neuropathy.
- Allergy to local anesthetics.
- Inflammatory arthropathies.
- Female patient who is pregnant or nursing.
- Chronic use of narcotics
- Any other reason (in the judgment of the investigator).
Sites / Locations
- Steadman Hawkins Clinic of the Carolinas - Greenville Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Exparel plus Adductor Canal Block
Exparel plus Placebo Block
Arm Description
Adductor canal block with 20 cc 0.5% Ropivacaine with 1:400,000 epinephrine and 100mcg of clonidine
Adductor canal block with 20 cc saline
Outcomes
Primary Outcome Measures
Pain as assessed by Visual Analog Scale (VAS)
Pain, as assessed by Visual Analog Scale (VAS)
Secondary Outcome Measures
Function as assessed by Knee Society Score (KSS) and EQ-5D
Function, as assessed by Knee Society Score (KSS) and EQ-5D
Opioid consumption as assessed by dosage and frequency of narcotic usage
Opioid consumption, as assessed by dosage and frequency of narcotic usage
Full Information
NCT ID
NCT02365727
First Posted
February 11, 2015
Last Updated
January 13, 2016
Sponsor
The Hawkins Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02365727
Brief Title
Exparel vs Exparel Plus ACB in TKAs
Official Title
Two-arm, Double-blind Randomized Study Comparing Exparel and Exparel Plus an Adductor Canal Block in Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Protocol not feasible as written
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hawkins Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients will be randomized (like the flip of a coin) to receive Exparel and a nerve block, standard of care for this procedure, or Exparel alone for pain management after surgery. They will also be asked to complete questionnaires before surgery, during their stay at the hospital after surgery, then at 3 months, 6 months and 12 months after surgery to assess pain and/or function levels, as well as the amount of pain medicine patients have used after surgery. Patients' leg strength will be measured immediately after surgery and again at 3, 6 and 12 months after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exparel plus Adductor Canal Block
Arm Type
Experimental
Arm Description
Adductor canal block with 20 cc 0.5% Ropivacaine with 1:400,000 epinephrine and 100mcg of clonidine
Arm Title
Exparel plus Placebo Block
Arm Type
Placebo Comparator
Arm Description
Adductor canal block with 20 cc saline
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Other Intervention Name(s)
Exparel
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Intervention Type
Drug
Intervention Name(s)
Clonidine
Intervention Type
Drug
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
Pain as assessed by Visual Analog Scale (VAS)
Description
Pain, as assessed by Visual Analog Scale (VAS)
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Function as assessed by Knee Society Score (KSS) and EQ-5D
Description
Function, as assessed by Knee Society Score (KSS) and EQ-5D
Time Frame
12 Months
Title
Opioid consumption as assessed by dosage and frequency of narcotic usage
Description
Opioid consumption, as assessed by dosage and frequency of narcotic usage
Time Frame
30 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, aged 18 to 80 years at the time of surgery.
Willing and able to give voluntary informed consent to participate in this investigation.
Candidate for total knee arthroplasty.
BMI < 35.
Exclusion Criteria:
Subject has had previous arthroplasty or fracture procedure(s) on the operative knee.
Creatine level ≥ 1.5
Pre-existing gait disturbance or neuropathy.
Allergy to local anesthetics.
Inflammatory arthropathies.
Female patient who is pregnant or nursing.
Chronic use of narcotics
Any other reason (in the judgment of the investigator).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brayton Shirley
Organizational Affiliation
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
12. IPD Sharing Statement
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Exparel vs Exparel Plus ACB in TKAs
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