A lottery trial for patients at increased risk of pain operated on with the insertion of artificial knees. After the operation, the draw will take place and the patient will either receive the active treatment, 1 tablet 24 mg. Dexamethasone / adrenocortical hormone or placebo tablet / not active treatment.

Phase 1

Conditions: Periooperative management of total knee-arthroplasty because of knee-osteoarthritis.
MedDRA version: 20.0Level: PTClassification code 10023469Term: Knee arthroplastySystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 20.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2020-006110-20-DK

Lead Sponsor: Vejle Sygehus, Ortopædkirurgisk afdeling, Forskningsenheden (COFU)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Inclusion criteria
•Age > 40
•Primary unilateral TKA
•Ability to participate in the study (understand written and spoken Danish language, self-reported pain and satisfaction).
•Signed written informed consent form
•PCS >20
•Moderate to severe postoperative pain (VAS >30) in a 5-meter walk test in the morning the first day after surgery between 8 am and 12 am (16-26 hours postoperatively).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

Exclusion criteria
•Ongoing treatment of systemic glucocorticoids or other immunosuppressant treatment apart from inhaled steroids.
•Insulin-dependent diabetes.
•Pregnancy or breastfeeding.*
•Allergies concerning the study-drug.
•Mental disability that could impair a patient’s decision-making capability of giving informed consent and not enabling valid data collection.
•Patients with known diagnoses of schizophrenia, ongoing psychosis, bipolar disease and/or a history of ongoing anti-psychotic treatment.
•Patients with modulated pain-reception (experience) based on other diseases or injuries, e.g. spinal cord or brain injury, severe polyneuropathies or neurologic disorders.

*Pregnancy: No women with suspected or proven pregnancy is eligible for inclusion.