Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of an intravenous (IV) perioperative dexamethasone regime in the clinical outcomes after a robotic-assisted Total Knee Arthroplasty (TKA) in a Hispanic population. The study aims to propose an alternative to opioid-based pain treatment following TKA. The study hopefully validates the use of a two-dose, 8mg intravenous dexamethasone regimen for improving pain and range of motion scores in patients undergoing primary, unilateral TKA for osteoarthritis. One dose will be applied prior to incision and the other at post-operative day (POD) 1.

Official Title
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Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population: A Randomized Controlled Trial

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Morphine
* Drug: Oxycodone and acetaminophen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with Hispanic self-identification Primary robotic-assisted TKA for treatment of primary osteoarthritis Age ≥ 21 Receiving seven days of inpatient rehabilitation after medical discharge Patient with adequate glycemic control (HbA1c<7.5%) Patients who provide written informed consent Exclusion Criteria: Age ≤ 21 Chronic steroid use prior to surgery Previous allergies or adverse reactions to steroid drugs Indications for surgery other than primary osteoarthritis History of narcotics abuse such as opioids Surgeries performed without robotic-assistance Outpatient or Home rehabilitation programs after medical discharge Requirement of revision surgery orthopaedic implants Patients with inadequate glycemic control (HbA1c≥7.5%) Other medical conditions, such as osteoporosis, fungal infections, glaucoma, joint infections, peptic ulcer disease which could worsen with steroid administration.

Ages Eligible for Study
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Minimum Age: 24 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients receiving intravenous dexamethasone<br> | Drug: Dexamethasone<br>* Two 8 mg doses. One dose applied prior to incision and the other at POD1<br>|
| Active Comparator: Patients receiving intravenous morphine and oral oxycodone<br> | Drug: Morphine<br>* Morphine 0.1 mg per kg intravenous every 6 hours<br>Drug: Oxycodone and acetaminophen<br>* 2 tabs of oral oxycodone combined with acetaminophen every 6 hours (the same pill includes both drugs)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POD 1 Visual Analogue Scale Pain Scores | Range: 0-10 (10 indicates highest degree of pain) | Measured at 7:00AM day after surgery | 
| POD 2 Visual Analogue Scale Pain Scores | Range: 0-10 (10 indicates highest degree of pain) | Measured at 7:00AM two days after surgery | 
| POD 3 Visual Analogue Scale Pain Scores | Range: 0-10 (10 indicates highest degree of pain) | Measured at 7:00AM three days after surgery | 
| POD 1 Range of Motion |  | Measured at 7:00AM the day after surgery | 
| POD 2 Range of Motion |  | Measured at 7:00AM two days after surgery | 
| POD 3 Range of Motion |  | Measured at 7:00AM three days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Dextrose Concentration (mg/dL) |  | Measured at 7:00AM for 3 days after surgery | 
| Length of Stay | Measured in days | From hospital admission to the date of discharge (About 3 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TKA, Primary osteoarthritis