Multimodal Pain Management Following Primary TKA

Study Overview
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Brief Summary
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The investigators plan to evaluate the length of time to discharge readiness between the groups (continuous femoral nerve blocks (cFNB) vs. liposomal bupivacaine (LB) vs. periarticular infusion cocktails (PIC) following primary total knee arthroplasty (TKA). In addition, the investigators will compare quadriceps strength recovery over time and exploratory variables between the groups.

Official Title
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Periarticular Infusion With Liposomal Bupivacaine or a Ropivacaine Cocktail Versus Continuous Femoral Nerve Catheters for Multimodal Pain Management Following Primary TKA: A Randomized Controlled Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: Exparel
* Drug: Ropivacaine cocktail (PIC)
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 40 Years Old Scheduled for Primary Total Knee Arthroplasty Exclusion Criteria: Opiate Tolerant (≥60mg/day oral morphine/equivalent for ≥1 week) 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: liposomal bupivacaine (LB) (Exparel)<br>Mixture of 50 milliliters (mL) of 0.25% Bupivacaine with epinephrine, 40 mL of sterile saline and 20 mL of Exparel®. | Drug: Exparel<br>* Mixture of 50 mL of 0.25% Bupivacaine with epinephrine, 40 mL of sterile saline and 20 mL of Exparel®.<br>|
| Active Comparator: Ropivacaine cocktail (PIC)<br>400 milligrams (mg) Ropivacaine, 5 mg morphine, and 0.4 mg epinephrine in 100 cc solution | Drug: Ropivacaine cocktail (PIC)<br>* 400 mg Ropivacaine, 5 mg morphine, and 0.4 mg epinephrine in 100 cc solution<br>|
| Active Comparator: continuous femoral nerve blocks (cFNB)<br>Continuous Femoral Nerve Block- 0.25% Bupivacaine at a rate of 5 ml/hour for 48 Hours. Sciatic nerve block - 0.125% bupivacaine | Drug: Bupivacaine<br>* Continuous Femoral Nerve Block- 0.25% Bupivacaine at a rate of 5 ml/hour for 48 Hours. Sciatic nerve block - 0.125% bupivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Discharge Readiness | Time to discharge readiness will be defined as the time from surgical stop to the time of the 2nd consecutive assessment where all criteria are fulfilled. | Participants will be followed for the duration of hospital stay, an average of 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Total Knee Arthroplasty