Pain Relief After PrimaryTKA

Study Overview
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Brief Summary
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While a majority of people who undergo TKA have significant long-term improvement in functional ability, many patients may experience significant pain in the early postoperative period, which may adversely impact postoperative rehabilitation and recovery. Traditionally, opioid medications have been used to control postoperative pain. However, there are many risks with using opioid medications, including addiction and overdose, which kills over 48,000 people yearly. In an effort to overcome this, opioid-sparing multimodal analgesia (MMA) regimens have been developed, commonly using nonsteroid anti-inflammatory drugs (NSAIDs), acetaminophen, regional nerve blocks, and local anesthesia.

Official Title
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Comparing the Efficacy of a Periarticular Instillation of Extended Relief Bupivacaine and Meloxicam With Routine Adductor Canal Blockade for Pain Relief After Primary TKA

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution
* Drug: Bupivacaine HCl 0.5% Injectable Solution
* Procedure: primary total knee replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years or older Patients undergoing primary unilateral TKA Patients receiving spinal anesthesia during primary TKA Patients with adequate cognitive function to participate and complete questionnaires for the study Exclusion Criteria: Patients undergoing bilateral simultaneous TKA Patients undergoing conversion TKA Patients undergoing unicompartmental knee arthroplasty Patients undergoing patellofemoral arthroplasty Patients with an allergy to NSAIDs or bupivacaine Patients who have a contraindication to the use of NSAIDs Patients who are using chronic anticoagulation, precluding them from using NSAIDs Patients with a history or diagnosis of chronic pain syndrome or complex regional pain syndrome Patients who are determined to be in severe pain from other concomitant conditions Patients with chronic opioid use disorder, defined as patients who are taking more than 20 mg/day morphine milligram equivalents for 30 days consecutively in the 3 months prior to surgery.

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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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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: primary total knee replacement + Zynrelef<br>Patients undergoing primary total knee replacement with Extended Relief Bupivacaine and Meloxicam (Zynrelef) | Drug: Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution<br>* zynrelef will be administered during surgery<br>Procedure: primary total knee replacement<br>* primary total knee replacement<br>|
| Active Comparator: primary total knee replacement + adductor canal block (ACB)<br>Patients undergoing primary total knee replacement with routine adductor canal block | Drug: Bupivacaine HCl 0.5% Injectable Solution<br>* adductor canal block will be performed using bupivacaine before surgery<br>Procedure: primary total knee replacement<br>* primary total knee replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | This will be measured by a postoperative Visual Analog Score (VAS) completed by the participant | 14 days | 
| Opioid consumption | Participants will be asked to keep a diary of how much pain medication they took after surgery | 14 days |