Overview

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

Status:
Completed
Trial end date:
2021-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Copenhagen University Hospital, Hvidovre
Collaborator:
Sygehus Lillebaelt
Treatments:
BB 1101
Dexamethasone
Dexamethasone acetate
Criteria
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.