CompletedPhase 4

High-Dose Steroid for Knee Arthroplasty Patients Expected to Have Postoperative Pain

Denmark88 participantsStarted 2019-01-29

Plain-language summary

The purpose of the Study is to test a higher dose of steroids(Dexamethasone) given just prior to surgery in the setting of Fast-Track Knee surgery with Arthroplasty in a group of expected High Pain Responders and the effect on postoperative pain and postoperative inflammation.

Who can participate

Age range

40 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 40 and 90. * Booked for unilateral knee-arthroplasty. * Is able to take part in the investigation(selfreported pain and nausea/vomiting) * Understands Danish or English, or has a translator available. * Signed written consent. * A daily use of 30 mg or more of morphine or morphine equivalents . * A pain catastrophizing scale(PCS) score of \>20. Exclusion Criteria: * Insulin-dependent diabetes melitus. * Ongoing treatment with systemic glucocorticoids or immunosuppressing treatment(apart from inhaled glucocorticoids). * Pregnancy/Breastfeeding * Allergies for the investigational drug. * A history of schizophrenia or bipolar diseases, or patients with permanent use of antipsychotic medication.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative pain after 24 hours: VAS

Timeframe: 24 hours

Trial details

NCT IDNCT03763734

SponsorCopenhagen University Hospital, Hvidovre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-01

View on ClinicalTrials.gov More Postoperative Pain trials

Who can participate

Age range

40 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.