Dexamethasone for Knee Surgery

No longer recruiting at 12 trial locations

Overseen By Vasili Karas, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rush University Medical Center

Must not be taking: Corticosteroids

Disqualifiers: Inflammatory arthritis, Renal or liver failure, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how different doses of dexamethasone, administered during knee surgery, can reduce pain, decrease opioid use, and enhance recovery. Participants are divided into three groups receiving 4mg, 8mg, or 16mg of dexamethasone to determine the optimal balance of effectiveness and safety. Individuals who have undergone a primary total knee replacement and will stay overnight in the hospital may be suitable for this study. As a Phase 4 trial, this research aims to understand how an FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used corticosteroids in the last 3 months.

What is the safety track record for dexamethasone?

Research has shown that dexamethasone is usually safe during surgery. One study found that a single dose of 5-10 mg did not increase the risk of post-surgical infections. Another review found that dexamethasone helps manage pain after knee surgery, though researchers are still determining the best dose and safety details. Multiple doses have helped recovery without causing major issues. Overall, this suggests dexamethasone is safe, but finding the right dose is important to minimize risks. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatment options for knee surgery, which often involve nonsteroidal anti-inflammatory drugs (NSAIDs) or opioids, dexamethasone offers a unique approach by using a corticosteroid to reduce inflammation and pain. Researchers are excited about this treatment because it works quickly, with intravenous administration shortly after anesthesia, potentially offering more immediate relief. Additionally, the trial is exploring varying doses—4mg, 8mg, and 16mg—to determine the most effective concentration, which could lead to more personalized and effective pain management strategies for patients undergoing knee surgery.

What is the effectiveness track record for dexamethasone in reducing postoperative opioid consumption and pain after knee surgery?

Studies have shown that dexamethasone effectively reduces pain after knee surgery. It manages pain and decreases the need for opioids, which are strong painkillers. In this trial, participants will receive different doses of dexamethasone: 4 mg, 8 mg, or 16 mg, administered shortly after anesthesia induction. Research indicates that all these doses reduce pain and improve sleep quality in patients who have had knee surgery. Specifically, a higher dose of 16 mg can also reduce vomiting and the need for opioids on the first day after surgery. Overall, dexamethasone helps manage pain and discomfort after knee surgery. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7220723/

The efficacy of dexamethasone on pain management for ... Primary outcomes: pain scores at 4–6 hours and 12 hours. These outcome data are analyzed with the random-effects model, and compared to control group for knee ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39284389/

A Triple Blind Randomized Controlled Trial Conclusions: Dexamethasone at doses of four, eight, and 16 mg effectively reduces pain and enhances sleep quality in patients undergoing TKA, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540325004619

What Is the Safest and Most Effective Dose of Intravenous ... High-dose (16 mg) IV dexamethasone in TKA reduces opioid consumption, pain, and vomiting on the first day after surgery. Outcomes, including opioid consumption ...

4. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(23)00404-7/fulltext

Oral Dexamethasone Following Total Knee Arthroplasty: A ... Intravenous dexamethasone has been shown to reduce pain in total joint arthroplasty. This double-blind, randomized, placebo-controlled trial ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2018/08310/a_meta_analysis_of_dexamethasone_for_pain.3.aspx

A meta-analysis of dexamethasone for pain management in... This meta-analysis revealed that administration of dexamethasone could significantly reduce postoperative pain at 12, 24, and 48 hours after TKA. Opioid ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30232525/

Infection safety of dexamethasone in total hip and ... In our study material, the use of a single 5-10 mg dose of dexamethasone did not increase the incidence of post-operative PJI.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11761980/

A systematic review and meta-analysis on the effects of ... This study is to assess the effects of intravenous dexamethasone administration on postoperative pain management and prognosis in patients undergoing TKA.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540324009434

Primary Knee Comparison of Dexamethasone at Three ... Dexamethasone has been shown to alleviate pain, yet the optimal dosing and safety profiles remain unclear. This study aimed to evaluate the analgesic ...

9. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-024-02530-9

The efficacy and safety of perioperative glucocorticoid for total ... Multiple doses of perioperative dexamethasone further improve clinical outcomes after total knee arthroplasty: a prospective, randomized.