Dexamethasone for Knee Arthropathy

(DEXA_PERIOP Trial)

Overseen By Gabe Schouten

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: Corticosteroids

Disqualifiers: Inflammatory arthritis, Renal 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: 7

Duration: 1 week

339 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different doses of dexamethasone, a type of corticosteroid, can aid individuals undergoing total knee replacement. The researchers aim to identify the optimal dose to reduce pain, decrease the need for pain medication, and minimize nausea and other post-surgery complications. Three different treatment schedules are being tested to determine the most effective one. Individuals having their first total knee replacement and who haven't recently used steroids may be suitable candidates for this trial. As a Phase 4 trial, this research seeks to understand how this already 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 have used corticosteroids in the last 3 months.

What is the safety track record for dexamethasone?

Research has shown that dexamethasone is generally safe for use around the time of knee surgery. Studies have found that it can reduce pain and the need for painkillers post-surgery. For example, one study found that individuals who took dexamethasone experienced less pain for up to 48 hours after surgery. Another study showed that a low dose of dexamethasone, adjusted for weight, effectively reduced pain.

Additionally, those who received dexamethasone reported lower pain levels in the days following surgery. While these studies focus on pain relief, they also suggest that dexamethasone is well-tolerated, with serious side effects being uncommon.

As this treatment is being tested in a later phase of clinical trials, extensive safety information is already available, confirming that dexamethasone is considered safe for use in this context. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Dexamethasone for knee arthropathy is unique because it explores different timing strategies for administering the drug to optimize pain relief and recovery post-surgery. Unlike standard treatments like NSAIDs or opioids, which primarily manage pain after it occurs, dexamethasone is given intraoperatively and shortly after surgery to preemptively reduce inflammation and pain. This approach could accelerate recovery times and minimize the need for stronger pain medications. Researchers are excited about the potential to improve patient outcomes by fine-tuning when and how dexamethasone is administered during the critical postoperative period.

What is the effectiveness track record for dexamethasone in knee arthropathy?

Research shows that dexamethasone reduces pain after knee surgery. In this trial, participants will receive dexamethasone in different regimens: administered intraoperatively at the time of anesthesia, intraoperatively and on the morning of the first postoperative day, or intraoperatively and on the mornings of the first and second postoperative days. Studies have found that doses of four, eight, and 16 mg can lessen pain and improve sleep for patients undergoing total knee replacement surgery. Higher doses, such as 16 mg, also decrease the need for opioids and reduce nausea and vomiting after surgery. Additionally, a review of several studies found that dexamethasone significantly reduces pain in the first 48 hours after surgery. Overall, dexamethasone aids in pain management and recovery after knee surgery. ^{4 5 6 7 8}

Who Is on the Research Team?

Charles Hannon

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals undergoing knee replacement surgery who are looking to reduce post-surgery pain, nausea, and complications. Specific eligibility details aren't provided, so it's best to contact the study organizers for more information on who can participate.

Inclusion Criteria

I am older than 18 years.

I am having or have had a total knee replacement.

Exclusion Criteria

Prior adverse reaction to corticosteroid

I have inflammatory arthritis.

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 one, two, or three doses of dexamethasone perioperatively during total knee arthroplasty

1 week

Intraoperative and postoperative visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including opioid consumption and sleeplessness

1 week

Daily monitoring for 7 days

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone

Trial Overview

The study aims to find out the most effective and safe way to use Dexamethasone around the time of surgery. It compares different dosing strategies: just IV (injected into a vein), IV with two days of oral pills, or another combination of IV and oral doses.

How Is the Trial Designed?

Group I: (3) dexamethasone administered intraoperatively, the morning of the first& second postoperative day Experimental Treatment 1 Intervention

(3) dexamethasone administered intraoperatively, the morning of the first postoperative day, and the morning of the second postoperative day.

Group II: (2) dexamethasone administered intraoperatively and on the morning of the first postoperative day, Experimental Treatment 1 Intervention

(2) dexamethasone administered intraoperatively and on the morning of the first postoperative day,

Group III: (1) dexamethasone administered intraoperatively at the time of anesthesia Experimental Treatment 1 Intervention

(1) dexamethasone administered intraoperatively at the time of anesthesia

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a study of 90 patients undergoing total knee arthroplasty, the combination of intravenous and topical dexamethasone significantly reduced postoperative pain and swelling compared to a control group receiving saline.

Patients receiving dexamethasone also experienced improved functional recovery, with greater range of motion and ambulation distance, as well as a lower incidence of postoperative nausea and vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of combining intravenous and topical dexamethasone against postoperative pain and function recovery after total knee arthroplasty: A prospective, double-blind, randomized controlled trial. Wu, C., Luo, D., Zhu, Y., et al.[2023]

In a study of 18,872 hip and knee arthroplasties, a single low dose of dexamethasone (5-10 mg) did not increase the risk of post-operative prosthetic joint infections (PJIs), indicating its safety for use in these surgeries.

Dexamethasone effectively prevents post-operative nausea and vomiting (PONV) and may help reduce post-operative pain without raising infection rates, making it a beneficial option in multimodal pain management for arthroplasty patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infection safety of dexamethasone in total hip and total knee arthroplasty: a study of eighteen thousand, eight hundred and seventy two operations. Vuorinen, MA., Palanne, RA., Mäkinen, TJ., et al.[2020]

In a study of 108 patients undergoing total knee arthroplasty, administering two doses of low-dose dexamethasone significantly reduced inflammatory markers (CRP and IL-6) and provided better pain relief compared to a placebo, particularly at 24 hours post-surgery.

Dexamethasone also decreased the incidence of postoperative nausea and vomiting (PONV) and postoperative fatigue, while showing no increase in the risk of surgical complications, indicating it is both effective and safe for enhancing recovery after knee surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two doses of low-dose perioperative dexamethasone improve the clinical outcome after total knee arthroplasty: a randomized controlled study. Xu, B., Ma, J., Huang, Q., et al.[2018]

Oral dexamethasone significantly reduced postoperative pain scores in patients undergoing total knee arthroplasty, particularly on postoperative days 2, 3, and 4, compared to a placebo group.

Despite the pain reduction, there were no significant differences in opioid usage, nausea, vomiting, or other complications between the dexamethasone and placebo groups, suggesting a favorable safety profile for this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The AAHKS Clinical Research Award: Oral Dexamethasone Following Total Knee Arthroplasty: A Double-Blind, Randomized Controlled Trial. Shaw, JH., Wesemann, LD., Banka, TR., et al.[2023]

In a study involving 100 patients with knee osteoarthritis, both triamcinolone hexacetonide (TH) and methylprednisolone acetate (MA) injections significantly reduced pain at 4 weeks, with sustained improvements observed up to 24 weeks.

There was no significant difference in efficacy between TH and MA, as both treatments showed similar outcomes in pain relief and functional improvement, indicating that either corticosteroid can be effectively used for managing knee OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Triamcinolone Hexacetonide versus Methylprednisolone Acetate Intraarticular Injections in Knee Osteoarthritis: A Randomized, Double-blinded, 24-week Study. Lomonte, AB., de Morais, MG., de Carvalho, LO., et al.[2022]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40339943/

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.

2.

orthopedicreviews.openmedicalpublishing.org

orthopedicreviews.openmedicalpublishing.org/article/143092-efficacy-of-weight-based-low-dose-intravenous-dexamethasone-for-pain-management-following-total-knee-arthroplasty-a-retrospective-case-matched-study

Efficacy of Weight-Based Low-Dose Intravenous ...

In conclusion, our study demonstrates that administering weight-based low-dose dexamethasone (0.1 mg/kg) effectively reduces postoperative pain ...

3.

sciencedirect.com

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

Primary Knee Comparison of Dexamethasone at Three ...

Conclusions. Dexamethasone at doses of four, eight, and 16 mg effectively reduces pain and enhances sleep quality in patients undergoing TKA, with the 16 mg ...

4.

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 ...

5.

link.springer.com

link.springer.com/article/10.1007/s00423-025-03618-7

A systematic review and meta-analysis on the effects of ...

Dexamethasone has shown promising efficacy in alleviating pain and enhancing outcomes undergoing TKA. However, an optimal route of ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29555525/

The efficacy and safety of dexamethasone for pain ...

Conclusion: Dexamethasone decreases pain scores within 48 h postoperatively and is associated with significantly reduced narcotic consumption.

7.

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.

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0883540323004047

Oral Dexamethasone Following Total Knee Arthroplasty: A ...

The patients who received dexamethasone had a statistically significant decrease in VAS scores when averaging POD 1 to 4 (P = .01). The average VAS scores among ...