The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Underg… (NCT03874936) | Clinical Trial Compass
CompletedPhase 2/3
The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Undergoing Periacetabular Osteotomy.
Denmark90 participantsStarted 2020-11-12
Plain-language summary
This is an investigator-initiated, Danish mono-center, randomized, placebo-controlled, parallel group, double-blind, superiority trial of dexamethasone on postoperative pain management on patients undergoing operation for hip dysplasia with the periacetabular osteotomy procedure (PAO). 90 adults undergoing PAO will be enrolled.
The primary outcome is to compare the effect of dexamethasone relative to placebo on cumulated postoperative morphine consumption at 48 hours.
Key secondary outcomes include comparing the effect of repeated doses of dexamethasone relative to a single dose on cumulated postoperative morphine consumption at 48 hours, and to determine if dexamethasone is superior to placebo for: Perception of pain intensity, prevalence and degree of postoperative nausea and vomiting, and patient-reported outcome measures.
Who can participate
Age range
18 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:
* Patients undergoing PAO due to symptomatic hip dysplasia (CE\<25grader) or retroverted acetabulum (crossover and posterior wall sign)
* ≥ 18 years
* Females if fertile: Verified negative human chorionic gonadotropin (HCG), usage of safe contraceptives or surgical sterilisation.
* Patients who give their written informed consent to participating in the trial, after having fully understood the content of the protocol and restrictions.
Exclusion Criteria:
* Patients who cannot speak or understand Danish
* Allergy or contraindications to trial medication
* Spinal anaesthesia
* Second intervention carried out simultaneously (e.g. femur osteotomy)
* Patients with daily opioid consumption prior to surgery (tramadol and codeine accepted)
* Drug, medical abuse or weekly alcohol consumption beyond ≥7 (female) and ≥14 (men) units, respectively.
* Mental disability, anxiety disorder (active psychiatric disorder or consumption of tricyclic antidepressants)
* Diabetes diagnosed prior to inclusion
* Immune suppression therapy (e.g. systemic glucocorticoids)
* Kidney impairment (eGFR \< 50ml/min) or liver disease (≥Child Pugh B)
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
1
Cumulated postoperative morphine consumption in milligrams after 48 hours.