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

Trial Summary

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 data supports the effectiveness of the drug Dexamethasone for knee arthropathy?

Research shows that Dexamethasone, when used during knee replacement surgery, can help reduce pain and swelling, and improve recovery. This suggests it might be effective for knee arthropathy by reducing inflammation and improving joint function. ^{1 2 3 4 5}

Is dexamethasone generally safe for use in humans?

Dexamethasone has been studied in various surgeries, including knee and hip replacements, and is generally considered safe for humans. However, it can have effects like raising blood sugar and suppressing the immune system, which are important to monitor. ^{1 3 6 7 8}

How is the drug dexamethasone unique for treating knee arthropathy?

Dexamethasone is unique for treating knee arthropathy because it can be used both intravenously and topically to reduce pain and swelling after knee surgery, potentially improving recovery. Its powerful anti-inflammatory effects may enhance the action of local anesthetics, offering better pain relief compared to other treatments. ^{4 5 9 10 11}

What is the purpose of this trial?

The purpose of this study is to determine the most efficient and safest dexamethasone dose given perioperatively during total knee arthroplasty that reduces postoperative option consumption and pain, improves postoperative nausea and vomiting, and minimizes postoperative complications

Research Team

Charles Hannon

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

I have inflammatory arthritis.

Prior adverse reaction to corticosteroid

I am under 18 years old.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Perioperative multiple low-dose Dexamethasones improves postoperative clinical outcomes after Total knee arthroplasty. [2019]

2. England pubmed.ncbi.nlm.nih.gov

The role of perioperative intravenous low-dose dexamethasone in rapid recovery after total knee arthroplasty: a meta-analysis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The AAHKS Clinical Research Award: Oral Dexamethasone Following Total Knee Arthroplasty: A Double-Blind, Randomized Controlled Trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Addition of dexamethasone to local infiltration analgesia in elective total knee arthroplasty: double-blind, randomized control trial. [2021]

5. England 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Effect of dexamethasone as an analgesic adjuvant to multimodal pain treatment after total knee arthroplasty: randomised clinical trial. [2022]

7. Germany 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. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

Two doses of low-dose perioperative dexamethasone improve the clinical outcome after total knee arthroplasty: a randomized controlled study. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Is Intraoperative Dexamethasone Utilization Associated With Increased Rates of Periprosthetic Joint Infection Following Total Joint Arthroplasty? [2023]

10. Canada pubmed.ncbi.nlm.nih.gov

Efficacy of Triamcinolone Hexacetonide versus Methylprednisolone Acetate Intraarticular Injections in Knee Osteoarthritis: A Randomized, Double-blinded, 24-week Study. [2022]

11. China pubmed.ncbi.nlm.nih.gov

[Application and research progress of dexamethasone in the perioperative period of joint arthroplasty and arthroscopic surgery]. [2023]