DEXRAR: DEXamethasone in Revision ARthroplasty

Summary

Trial name: DEXRAR: Dexamethasone in revision arthroplasty: A randomised, blinded, 2-group clinical trial Trial acronym: DEXRAR Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No "gold standard" exists for pain treatment after revision total knee arthroplasty (TKA) and combinations of different medications are used with virtually no evidence for combined analgesic efficacy. Objectives: The objective is to investigate the analgesic effect and safety of dexamethasone as a single dose after revision-TKA in combination with paracetamol, ibuprofen and local infiltration analgesia Intervention: The patients are randomised into to groups: A) 24 mg dexamethasone i.v. B) isotonic saline i.v. Design and trial size: Placebo controlled, parallel 2-group trial with adequate centralised computer-generated allocation sequence and allocation concealment with block size of 12. Blinding of assessor, investigator, caregivers and patients. Sample size: 108 eligible patients are needed to detect a difference of 11,3 mg morphine for the first 24 h postoperatively with a standard deviation of 20 mg, a type 1 error rate of 0,05 and a type 2 error rate of 0,20.

Timeline

Start

2017-05-31

Primary completion

2024-12-31

Completion

2025-03-31

Outcome

Outcome not reported

Stopped (Enrollment): “The study had met its original objectives for the primary endpoint. A transition to a new regulatory system would have introduced additional costs and delays. Therefore, a strategic decision was made to stop before final enrollment.”

Drugs

Indications