Status:
COMPLETED
The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Undergoing Periacetabular Osteotomy.
Lead Sponsor:
Odense University Hospital
Collaborating Sponsors:
Odense Patient Data Explorative Network
Conditions:
Dexamethasone
Hip Dysplasia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 und...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03874936
Start Date
November 12 2020
End Date
December 31 2023
Last Update
April 2 2024
Active Locations (1)
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1
Odense University Hospital
Odense, Denmark, 5000