Status:
COMPLETED
High-Dose Steroid for Hip Arthroplasty Patients Expected to Have Postoperative Pain
Lead Sponsor:
Copenhagen University Hospital, Hvidovre
Collaborating Sponsors:
Sygehus Lillebaelt
Conditions:
Postoperative Pain
Postoperative Nausea and Vomiting
Eligibility:
All Genders
40-90 years
Phase:
PHASE4
Brief 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 Hip-surgery with Arthroplasty in a group of expected High Pain Res...
Detailed Description
This study compares a new High-Dose dosage of steroids in the treatment of postoperative pain after Hip Arthroplasty in a Fast-Track setting in a group of expected High Pain Responders. The investiga...
Eligibility Criteria
Inclusion
- Age between 40 and 90.
- Booked for unilateral Hip-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
- 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.
Key Trial Info
Start Date :
January 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03763760
Start Date
January 29 2019
End Date
January 1 2021
Last Update
June 30 2021
Active Locations (2)
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1
Hvidovre Hospital, Capital Region of Denmark.
Hvidovre, Denmark, 2650
2
Vejle Sygehus
Vejle, Denmark, 7100