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 range18 Years
SexALL
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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)
What they're measuring
1
Cumulated postoperative morphine consumption in milligrams after 48 hours.