Dexamethasone for Knee Arthropathy
(DEXA_PERIOP Trial)
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.12345Why 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.45678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one, two, or three doses of dexamethasone perioperatively during total knee arthroplasty
Follow-up
Participants are monitored for safety and effectiveness after treatment, including opioid consumption and sleeplessness
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Immune system disorders
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
- Neoplastic diseases
- Nervous system disorders
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor