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DEXRAR: DEXamethasone in Revision ARthroplasty: A Randomised, Blinded, 2-group Clinical Trial

2016-08-31 15:23:21 | BioPortfolio

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Pain, Postoperative

Intervention

Dexamethasone, Saline isotonic

Location

Næstved Hospital
Nøstved
Region Zealand
Denmark
4700

Status

Not yet recruiting

Source

Naestved Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-08-31T15:23:21-0400

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