Study Stopped
Protocol not feasible as written
Exparel vs Exparel Plus ACB in TKAs
Two-arm, Double-blind Randomized Study Comparing Exparel and Exparel Plus an Adductor Canal Block in Total Knee Arthroplasty
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2015
Shorter than P25 for phase_4 knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2015
CompletedFirst Posted
Study publicly available on registry
February 19, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedJanuary 14, 2016
January 1, 2016
4 months
February 11, 2015
January 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Pain as assessed by Visual Analog Scale (VAS)
Pain, as assessed by Visual Analog Scale (VAS)
12 Months
Secondary Outcomes (2)
Function as assessed by Knee Society Score (KSS) and EQ-5D
12 Months
Opioid consumption as assessed by dosage and frequency of narcotic usage
30 hours
Study Arms (2)
Exparel plus Adductor Canal Block
EXPERIMENTALAdductor canal block with 20 cc 0.5% Ropivacaine with 1:400,000 epinephrine and 100mcg of clonidine
Exparel plus Placebo Block
PLACEBO COMPARATORAdductor canal block with 20 cc saline
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
Greenville, South Carolina, 29615, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brayton Shirley
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2015
First Posted
February 19, 2015
Study Start
April 1, 2015
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
January 14, 2016
Record last verified: 2016-01