Adductor Canal Catheter Effectiveness and Safety Study

Study Overview
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Brief Summary
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PRIMARY OBJECTIVE: Compare the effect of usual care with an adductor canal catheter (ACC) containing ropivacaine to the effect of usual care without an ACC on the second-postoperative-day pain levels among patients undergoing elective primary unilateral total knee arthroplasty (TKA) SECONDARY OBJECTIVES: Among a sample of patients undergoing elective primary unilateral TKA who receive peri-articular anesthetic injections: To compare the overall two-week levels of postoperative pain between those participants randomized to ACCs containing ropivacaine and those participants randomized to usual care without an ACC To compare the use of opioid medications (in mean total morphine milligram equivalents) between those participants randomized to ACCs containing ropivacaine and those participants randomized to usual care without an ACC over the two-week postoperative period To describe the incidence of complications related to ACC placement including infection, displacement, ACC-related clinic or emergency department (ED) visits To conduct exploratory analyses to identify candidate predictors of differential response to the ACC

Detailed Description
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DESIGN: Randomized, open-label, two-arm, parallel-comparison noninferiority trial POPULATION: Adults aged >18 years intending to undergo elective primary unilateral TKA at the Kaiser Permanente Northern California, San Leandro Medical Center INTERVENTION: Participants will be randomized to one of two treatment arms: Adductor canal catheter placement in the pre-operative area immediately prior to TKA surgery OR No adductor canal catheter placement DURATION: The intervention phase will occur between randomization and three days postoperatively (or until the ACC is removed by the participant or the ACC falls out spontaneously among ACC-randomized participants); the primary outcome will be measured on postoperative day 2, secondary pain and medication outcomes will be collected for two weeks postoperatively and the electronic medical record (EMR) will be examined for evidence of adverse events at 3 months postoperatively SAMPLE SIZE: 118 participants randomized using balanced allocation to the two study arms

Official Title
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An Open-Label Randomized Noninferiority Clinical Trial of the Adductor Canal Catheter for Pain Control Post-Total Knee Arthroplasty

Conditions
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Total Knee Replacement Surgery

Intervention / Treatment
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* Device: Adductor Canal Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intending to undergo elective primary unilateral TKA at the KPNC San Leandro Medical Center Patient ambulates independently Exclusion Criteria: Patient declines use of ACC Surgeon decides that an ACC will not be placed for any reason Known hypersensitivity to ropivacaine or any alternative anesthetic for ACC use Hypersensitivity or inability to tolerate peri-articular injections of clonidine, epinephrine, bupivacaine and ketorolac Any evidence of substance-use disorder in past year Non-English speaking Failure to complete all baseline study instruments prior to surgery Requires secondary procedure at time of TKA (e.g., removal of hardware) Not intending to use spinal anesthesia for TKA procedure Actively enrolled in KPNC chronic-pain program Having been prescribed long-acting opioid (e.g., Oxycontin, MS Contin) within 90 days prior to enrollment Inability to tolerate any oral NSAID or acetaminophen or any short-acting opioid

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No-Device<br>No placement of an adductor canal catheter | |
| Experimental: Device<br>Placement of an adductor canal catheter | Device: Adductor Canal Catheter<br>* The adductor canal catheter is a medical device that consists of a tunneled catheter connected to an analgesic solution-containing reservoir that slowly infuses the anesthetic over the first 2-3 postoperative days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Numerical Rating Scale | Ordinal 0-to-10 point scale of pain severity | Second postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcomes Score (KOOS) Jr | Multidimensional instrument for assessing pain, symptoms, activities of daily living, recreation functioning, and knee-related quality of life; this is an ordinal scale, scored on a 1-to-28 scale with higher numbers indicating more severe symptoms | 14th postoperative day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesia, surgery, device