Exparel vs Exparel Plus ACB in TKAs

Study Overview
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Brief Summary
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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.

Official Title
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Two-arm, Double-blind Randomized Study Comparing Exparel and Exparel Plus an Adductor Canal Block in Total Knee Arthroplasty

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: Ropivacaine
* Drug: Epinephrine
* Drug: Clonidine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exparel plus Adductor Canal Block<br>Adductor canal block with 20 cc 0.5% Ropivacaine with 1:400,000 epinephrine and 100mcg of clonidine | Drug: Liposomal bupivacaine<br> <br> * Other names: Exparel;Drug: Ropivacaine<br> <br> Drug: Epinephrine<br> <br> Drug: Clonidine<br> <br> |
| Placebo Comparator: Exparel plus Placebo Block<br>Adductor canal block with 20 cc saline | Drug: Liposomal bupivacaine<br> <br> * Other names: Exparel;Drug: Saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as assessed by Visual Analog Scale (VAS) | Pain, as assessed by Visual Analog Scale (VAS) | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function as assessed by Knee Society Score (KSS) and EQ-5D | Function, as assessed by Knee Society Score (KSS) and EQ-5D | 12 Months | 
| Opioid consumption as assessed by dosage and frequency of narcotic usage | Opioid consumption, as assessed by dosage and frequency of narcotic usage | 30 hours |