A Study to Compare the Effectiveness of Adductor Canal Pain Catheters Following Total Knee Arthroplasty

Study Overview
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Brief Summary
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The purpose of this research is to study how well the adductor canal pain catheters works after a total knee arthroplasty or replacement of the knee joint. The catheter works by using either an intermittent bolus injection to provide a large dose of medication or continuous infusion of pain medicine, ropivacaine 0.2%, compared to a single-shot adductor canal block.

Official Title
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A Three-Arm, Double-Blinded, Randomized Controlled Trial Comparing the Efficacy of Adductor Canal Pain Catheters Following Total Knee Arthroplasty

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: Ropivacaine Continuous Infusion
* Drug: Ropivacaine Intermittent Bolus
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 and ≤ 90 years. Willing to participate in the study and competent to provide informed consent. Willing to comply with protocol procedures. Has an underlying diagnosis of osteoarthritis indicated for a total knee arthroplasty. Exclusion Criteria: The patient must not have taken any narcotic medications (schedule II) during the 3 months leading up to the surgery. The patient must not be allergic or intolerant to a medication used in the multimodal pain pathway. Revision knee arthroplasty. Uncontrolled diabetes with A1C > 8.0%.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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
Interventional Model Description: A Three-Arm, Double-Blinded, Randomized Controlled Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine group with bolus infusions<br>Subjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in pulsed intermittent bolus. | Drug: Ropivacaine Intermittent Bolus<br>* 0.2% intermittent bolus infusion 8mL every 2 hours<br>|
| Experimental: Ropivacaine group with continuous infusions<br>Subjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in a continuous infusion. | Drug: Ropivacaine Continuous Infusion<br>* 0.2% continuous infusion 6mL/hr<br>|
| Placebo Comparator: Single shot adductor canal block group<br>Subjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with saline. | Drug: Placebo<br>* Saline filled catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain levels | Measured using a visual analogue scale (VAS) where subject places a mark on a horizontal line to rate the intensity of their pain at the time between no pain and worst pain imaginable. | 14 days post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of medication administered | Amount of medication administered via the patient-controlled function on the adductor catheter | 60 days, or until discontinuation of narcotic medication (whichever is later) | 
| Duration of narcotic used | Number of days narcotic use is required | 60 days, or until discontinuation of narcotic medication (whichever is later) |