Dexamethasone in Total Knee Arthroplasty

Study Overview
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Brief Summary
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The purpose of this study is to determine the most efficacious and safest dexamethasone dose given intraoperatively during total knee arthroplasty that reduces postoperative opioid consumption and pain, improves postoperative nausea and vomiting, and minimizes postoperative complications.

Detailed Description
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Study design: Prospective randomized controlled trial Scientific Background: In contemporary total joint arthroplasty (TJA), multimodal anesthesia and analgesia is used to improve postoperative pain, reduce opioid consumption, and minimize complications after surgery such as postoperative nausea and vomiting.1-3 Multiple medications with varying mechanisms of action are used at different time points throughout the perioperative period to modulate different pain receptors. Corticosteroids are a medication commonly utilized intraoperatively as part of contemporary multimodal protocols. Corticosteroids are frequently used in TJA due to their potent anti-inflammatory and anti-emetic properties. Several studies have demonstrated that corticosteroids reduce postoperative nausea and vomiting as well as postoperative pain and opioid consumption.4-6 However, the optimal medication, dose, and number of doses of corticosteroid that should be administered in the perioperative period remain unknown. In addition, it remains unclear if corticosteroids can be safely used in patients with diabetes mellitus or if corticosteroids increase the risk of postoperative complications such as periprosthetic joint infection. Thus, the purpose of our study is to determine the most efficacious and safest dose of corticosteroids that should be administered intraoperatively during TJA.

Official Title
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Dexamethasone in Total Knee Arthroplasty: What Dose Should we be Giving Patients Intraoperatively

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Drug: Dexamethasone 4mg
* Drug: Dexamethasone 8 Mg/mL Injectable Suspension
* Drug: Dexamethasone 16mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Primary total knee arthroplasty Patients staying at least one night in the hospital after surgery Exclusion Criteria: Same day discharge Age < 18 years Revision or partial total knee arthroplasty Corticosteroid use within 3 months prior to surgery Inflammatory arthritis Current systemic fungal infection Renal or liver failure Prior adverse reaction to corticosteroid Primary TKA requiring hardware removal

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>4mg intravenous dexamethasone, administered shortly after induction of anesthesia | Drug: Dexamethasone 4mg<br>* 4mg intravenous dexamethasone, administered shortly after induction of anesthesia<br>* Other names: Group 1;|
| Active Comparator: Group 2<br>8mg intravenous dexamethasone, administered shortly after induction of anesthesia | Drug: Dexamethasone 8 Mg/mL Injectable Suspension<br>* 8mg intravenous dexamethasone, administered shortly after induction of anesthesia<br>* Other names: Group 2;|
| Active Comparator: Group 3<br>16mg intravenous dexamethasone, administered shortly after induction of anesthesia | Drug: Dexamethasone 16mg<br>* 16mg intravenous dexamethasone, administered shortly after induction of anesthesia<br>* Other names: Group 3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | 48 hours of cumulative opioid consumption measured in oral morphine equivalents | 48-hours postoperative (after surgical intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain scores at rest and with activity | Using daily Defense and Veterans Pain Rating scale to rate pain at rest and with activity | Immediately after surgical intervention (TKA) for days 1 through 7 after surgery | 
| Postoperative nausea and vomiting | Using numeric rating scale, (1-10, where 10 is most nausea, causing vomiting followed by number of times participant vomited in 24-hour period). | Immediately after surgical intervention (TKA) for days 1 through 7 after surgery. Using numeric rating scale. | 
| Postoperative Blood glucose levels and insulin use | check glucose levels in daily blood draws when inpatient at hospital, insulin if applicable | Immediately following surgical intervention until discharge from hospital (up to 30 days after surgery if still in hospital) | 
| Length of stay | Days inpatient at hospital after surgery | immediately following surgery (intervention), number of days spent in the hospital after surgery to discharge, up to 30 days after intervention | 
| Sleeplessness/insomnia | recorded by patient, daily sleep schedule | Immediately after surgical intervention (TKA) for days 1 through 7 after surgery, recording 24 hour sleep patterns | 
| Number of participants with complications (such as readmission to hospital) up to 30 days after surgical intervention | Readmission after surgery, infection, VTE, GI hemorrhage or any other complication that requires rehospitalization | <30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexamethasone, opioid consumption, postoperative pain