Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
EARLY_PHASE1
84 participants
INTERVENTIONAL
2014-09-30
2017-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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liposomal bupivacaine (LB) (Exparel)
Mixture of 50 milliliters (mL) of 0.25% Bupivacaine with epinephrine, 40 mL of sterile saline and 20 mL of Exparel®.
Exparel
Mixture of 50 mL of 0.25% Bupivacaine with epinephrine, 40 mL of sterile saline and 20 mL of Exparel®.
Ropivacaine cocktail (PIC)
400 milligrams (mg) Ropivacaine, 5 mg morphine, and 0.4 mg epinephrine in 100 cc solution
Ropivacaine cocktail (PIC)
400 mg Ropivacaine, 5 mg morphine, and 0.4 mg epinephrine in 100 cc solution
continuous femoral nerve blocks (cFNB)
Continuous Femoral Nerve Block- 0.25% Bupivacaine at a rate of 5 ml/hour for 48 Hours.
Sciatic nerve block - 0.125% bupivacaine
Bupivacaine
Continuous Femoral Nerve Block- 0.25% Bupivacaine at a rate of 5 ml/hour for 48 Hours.
Sciatic nerve block - 0.125% bupivacaine
Interventions
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Exparel
Mixture of 50 mL of 0.25% Bupivacaine with epinephrine, 40 mL of sterile saline and 20 mL of Exparel®.
Ropivacaine cocktail (PIC)
400 mg Ropivacaine, 5 mg morphine, and 0.4 mg epinephrine in 100 cc solution
Bupivacaine
Continuous Femoral Nerve Block- 0.25% Bupivacaine at a rate of 5 ml/hour for 48 Hours.
Sciatic nerve block - 0.125% bupivacaine
Eligibility Criteria
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Inclusion Criteria
* Scheduled for Primary Total Knee Arthroplasty
Exclusion Criteria
* Neuromuscular deficit affecting the lower limbs
* Peripheral neuropathy
* Radiculopathy/Sciatica
* Known allergy or intolerance to Bupivacaine or Ropivacaine
* Hepatic Disease
* Renal Disease/Patients needing Dialysis
* Planned unicompartmental knee replacement
* Less than 90 degree of knee flexion preoperatively.
* Patients who lack the capacity to consent or are unwilling to do so
* At the discretion of the PI, patients who may have difficulty complying with standard of care (SOC) followup may also be excluded
40 Years
90 Years
ALL
No
Sponsors
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University of Utah
OTHER
Responsible Party
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Christopher Pelt
M.D.
Principal Investigators
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Christopher Pelt, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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University of Utah Orthopaedic Center
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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74975
Identifier Type: -
Identifier Source: org_study_id
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