Exparel Use in Adductor Canal Block After Total Knee Arthroplasty

Study Overview
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Brief Summary
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Exparel has been shown to have better pain control compared to previously used infiltration agents, including bupivacaine, while having a minor side effect profile. The purpose of this study is to explore the effectiveness of Exparel (liposomal bupivacaine) in Adductor Canal Blocks for peri-operative pain control following a total knee arthroplasty (TKA) procedure.

Detailed Description
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The effectiveness of an Exparel Block (Bupivacaine Liposomal Injectable Suspension) for post-operative pain control has been well studied with encouraging results. At the investigators' institution, Exparel has been approved as a safe and effective option for use in shoulder surgeries and have had encouraging results in adductor canal use for pain control in patients undergoing TKA. Exparel has been shown to have better pain control compared to previously used infiltration agents, including bupivacaine, while having a minor side effect profile. The purpose of this study is to explore the effectiveness of Exparel (liposomal bupivacaine) in Adductor Canal Blocks (ACB) for peri-operative pain control following a total knee arthroplasty (TKA) procedure. Specifically, the investigators look to see if Exparel ACB reduces opioid requirement use post-operatively, reduces pain scores post-operatively, provides earlier mobilization, and decreases length of hospital stay.

Official Title
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Adductor Canal Blocks Using Exparel for Pain Control After Total Knee Arthroplasty

Conditions
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Arthritis Knee, Pain, Postoperative, Opioid Use

Intervention / Treatment
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* Drug: Exparel
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients were eligible for inclusion if they were undergoing unilateral primary TKA for a diagnosis of knee osteoarthritis and were not undergoing any additional concomitant procedures were. Exclusion Criteria: Patients were not eligible for our study if they were undergoing revision TKA, if they were undergoing bilateral TKA or concomitant procedures, or if they had an active infection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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<br>Liposomal Bupivacaine use as active ingredient in the block | Drug: Exparel<br>* Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine<br>|
| Active Comparator: Control<br>Ropivacaine use as active ingredient in the block | Drug: Ropivacaine<br>* Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Length of Stay | Inpatient post-operative stay after undergoing TKA procedure | Through entire inpatient hospital stay (lasted from 1 day to 1 week) | 
| Inpatient Opioid Use | Opioid usage during their inpatient post-operative hospital stay | 1 week | 
| Numeric Rating Scale (NRS) Pain Score Improvement | Measured with Numerical Rating Scale (Range: 0-10, Minimum:0, Maximum:10). Change in NRS Pain Score from pre-operative levels. Positive changes indicate a decrease in pain levels from pre-operative levels. | 6 weeks | 
| Outpatient Opioid Use | Opioid usage in the immediate post-operative period after hospital discharge | 6 weeks | 
| WOMAC Score | Western Ontario and McMaster Universities Osteoarthritis Index Patient Subjective Outcome Score (Range: 0-96, Minimum:0, Maximum:96). Subsections include Pain (Range:0-20, Minimum:0, Maximum:20), Stiffness (Range:0-8; Minimum:0, Maximum:8), and Functional Limitation (Range0-68, Minimum:0, Maximum:68). Measured as change in score from baseline levels. Positive scores indicate an improvement in WOMAC scores from pre-operative levels. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Needing to be Readmitted to the Hospital Secondary to Inadequate Pain Control Post-operatively | Rate of needing to be readmitted to the hospital secondary to inadequate pain control post-operatively at any point during the study period. | 6 weeks | 
| Number of Participants Needing to be Admitted to an Inpatient Rehabilitation Facility Post-Operatively | Rate of needing to be discharged to an inpatient rehabilitation facility after TKA procedure secondary to inadequate pain control and functional recovery | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exparel, adductor, knee, arthroplasty, opioid