Dexamethasone Twice for Pain Treatment of Total Knee Arthroplasty

• Status: Completed
• Trial end date: 2020-06-07
• Target enrollment: 0
• Participant gender: All

Summary

Dexamethasone twice for pain treatment after total knee arthroplasty - A Placebo-controlled, randomised, parallel 3-group multicentre trial of one and two doses of dexamethasone for postoperative treatment

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Naestved Hospital
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Scheduled for unilateral, primary total knee arthroplasty

• ASA 1-3

• BMI ≥ 18.0 and ≤ 40.0

• Negative urine HCG pregnancy test and use of anti-conception for women in the fertile age

• Patients who gave their written informed consent to participating in the trial after having fully understood the contents of the protocol and restrictions

Exclusion Criteria:

• Patients who cannot cooperate with the trial

• Concomitant participation in another trial involving medication

• Patients who cannot understand or speak Danish

• Patients with allergy to medication used in the trial

• Patients with daily use of high dose opioid (> oral morphine 30 mg/day or oxycodone 30 mg/day or tramadol 150 mg/day) or any use of other opioids including methadone and transdermal opioids.

• Patients with at daily use of systemic glucocorticoids

• Contraindications against ibuprofen or paracetamol, for example previous ulcer, known heart failure, known liver failure, or known renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (<100 bil/l); or against treatment with glucocorticoids.

• Dysregulated diabetes (investigators judgement)

• Patients suffering from alcohol and/or drug abuse - based on the investigator's judgement