Trial name: DEXRAR: Dexamethasone in revision arthroplasty: A randomised, blinded, 2-group
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
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.