Dexamethasone for Knee Surgery

Recruiting at 11 trial locations

Overseen By Vasili Karas, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rush University Medical Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Immediate perioperative period

404 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I am older than 18 years.

I stayed in the hospital overnight after my surgery.

I am having or have had a total knee replacement.

Exclusion Criteria

I need to have hardware removed from my knee replacement.

I have a fungal infection in my body.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous dexamethasone during total knee arthroplasty to determine the most efficacious and safest dose

Immediate perioperative period

1 visit (in-person, surgical procedure)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including opioid consumption, pain, nausea, and complications

30 days

Daily monitoring during hospital stay, follow-up visits as needed

Treatment Details

Interventions

• Dexamethasone

Trial Overview 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.

Participant Groups

Group I: Group 1 Active Control 1 Intervention

4mg intravenous dexamethasone, administered shortly after induction of anesthesia

Group II: Group 2 Active Control 1 Intervention

8mg intravenous dexamethasone, administered shortly after induction of anesthesia

Group III: Group 3 Active Control 1 Intervention

16mg intravenous dexamethasone, administered shortly after induction of anesthesia

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+