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.