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Dexamethasone for Knee Surgery

Phase 4

Waitlist Available

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years

Patients staying at least one night in the hospital after surgery

Must not have

Primary TKA requiring hardware removal

Current systemic fungal infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up <30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgery

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether a lower dose of the steroid dexamethasone given during surgery can reduce postoperative pain and the need for opioids without increasing other complications.

Who is the study for?

This trial is for adults over 18 who are staying in the hospital at least one night after a primary total knee replacement surgery. It's not for those with inflammatory arthritis, current fungal infections, kidney or liver failure, planned same-day discharge, recent corticosteroid use, or a history of bad reactions to steroids.

What is being tested?

The study is testing three different doses of dexamethasone (16mg, 8mg/mL suspension, and 4mg) given during knee replacement surgery. The goal is to see which dose best reduces pain and opioid need after surgery while also lowering nausea/vomiting and complications.

What are the potential side effects?

Dexamethasone may cause side effects like increased blood sugar levels, higher risk of infection due to immune suppression, mood swings or sleep disturbances. Long-term use can lead to bone loss or stomach ulcers but this trial involves a single dose.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I stayed in the hospital overnight after my surgery.

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I am having or have had a total knee replacement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need to have hardware removed from my knee replacement.

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I have a fungal infection in my body.

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I am under 18 years old.

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I will be discharged from the hospital on the same day of my procedure.

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I have inflammatory arthritis.

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I have kidney or liver failure.

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I am having or have had a partial or complete knee replacement surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ <30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~<30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and <30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgery for reporting.