The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty

Study Overview
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Brief Summary
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It is well recognized that a multimodal analgesia program targeting multiple pain pathways, is more effective for controlling pain during the hospital stay and in the acute postoperative period than monotherapy-based regimens, such as opioids only. This multimodal analgesic regimen also leads to reduce opioid consumption and its related side effects after hip and knee joint replacement procedures. One potential strategy to reduce the use of opioids after TKA is to administer a prolonged oral multimodal pain regimen that targets multiple pain pathways in the post hospital discharge period. This can be equal or more effective than the regimen of opioid prescriptions used after TKA. To the best of our knowledge, there have been no studies conducted that directly examine the effect of prolonged multimodal pain regimen after hospital discharge in primary TKA patients. PURPOSE: To determine whether a prolonged multimodal pain regimen after discharge from primary TKA can provide equivalent or better pain control while reducing opioid consumption and, subsequently, opioid-related side effects. To determine whether patient expectations and routine opioid prescription practices at the time of discharge from primary TKA impacts opioid consumption.

Official Title
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The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty

Conditions
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Osteo Arthritis Knee

Intervention / Treatment
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* Drug: Oxycodone
* Drug: Tramadol
* Drug: Tylenol
* Drug: Meloxicam
* Drug: Gabapentin
* Drug: Metaxalone
* Drug: Esomeprazole 20mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis. ASA I - III Spinal anesthesia All patients will have cemented total knee utilizing a medial parapatellar approach including patellar resurfacing. A tourniquet will be used in all cases Male and Female over 18 who are willing and able to provide informed consent Exclusion Criteria: Opioid use within 3 months preoperatively Inability to take the protocol medications Anticoagulant other than aspirin Contraindication to regional anesthesia Non-english speaking ASA IV or greater Psychiatric or cognitive disorders Allergy/contraindications to protocol medications. Renal insufficiency with Cr > 2.0 or hepatic failure General anesthesia Sensory/motor disorder involving the operative limb

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 |
| --- | --- |
| Active Comparator: Opioid Regimen<br>Weeks 1-4 Oxycodone 5 mg PRN q4h (30 tablets) Tramadol 50 mg PRN q6h (30 tablets) | Drug: Oxycodone<br>* Patients are given, for up to 4 weeks, Oxycodone 5m PRN every four hours (up to 30 tablets)<br>Drug: Tramadol<br>* Patients are given, for up to 4 weeks, Tramadol 50mg PRN every 6 hours (up to 30 tablets)<br>|
| Experimental: Multimodal pain regimen with PRN opioids<br>Weeks 1-4 Tylenol 1000 mg q8h (standing) Meloxicam 15 mg qD (standing). Gabapentin 200 mg BID (with morning and evening Tylenol dose) Metaxalone 800mg PO TID (Tizanidine 2mg q8h if insurance coverage is not possible for metaxalone) Esomeprazole 20mg daily if not already on another H2 blocker or PPI Oxycodone 5 mg PRN q4h (30 tablets) Tramadol 50 mg PRN q6h (30 tablets) | Drug: Oxycodone<br>* Patients are given, for up to 4 weeks, Oxycodone 5m PRN every four hours (up to 30 tablets)<br>Drug: Tramadol<br>* Patients are given, for up to 4 weeks, Tramadol 50mg PRN every 6 hours (up to 30 tablets)<br>Drug: Tylenol<br>* Tylenol 1000 mg: take as needed every 8 hours<br>Drug: Meloxicam<br>* Meloxicam 15 mg as need once per day<br>Drug: Gabapentin<br>* •Gabapentin 200 mg with morning and evening Tylenol dose<br>Drug: Metaxalone<br>* Metaxalone 800mg TID<br>Drug: Esomeprazole 20mg<br>* Esomeprazole 20mg daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | Measured via Visual Analog scale (0-100mm) | Postsurgery days 1-30 | 
| Opioid related side effects | Severity measured via Visual Analog scale (0-100mm) | post-surgery days 1-30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid consumption | morphine milligram equivalent | post-surgery weeks 1-4 | 
| opioid consumption | number of pills consumed | post-surgery weeks 1-4 | 
| number of opioid refills | number of times subjects asked to have an opioid prescription refilled during post-operative period | post-surgery weeks 1-4 | 
| 90 day complications | collection of all post-operative medical complications within the first 90 days after surgery | post-surgery 90 days |