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NCT02884180: DEXRAR

DEXRAR: DEXamethasone in Revision ARthroplasty

Terminated Phase 4 Last updated 23 May 2025
What this trial tests

Phase 4 trial testing Dexamethasone in Pain, Postoperative in 98 participants. Terminated before completion.

Timeline
31 May 2017
Primary endpoint
31 December 2024
31 March 2025

Quick facts

Lead sponsorDaniel Hägi-Pedersen
PhasePhase 4
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment98
Start date31 May 2017
Primary completion31 December 2024
Estimated completion31 March 2025
Sites1 location across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

Daniel Hägi-Pedersen — full company profile →

Who can join

18 and older, any sex, with Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis.
    Weibel S, Rücker G, Eberhart LH, Pace NL, et al · · 2020 · cited 125× · PMID 33075160 · DOI 10.1002/14651858.cd012859.pub2

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Other trials of Dexamethasone

Trials testing the same drug.

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Currently open trials in the same condition.

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