MedTrace Logo

DEXRAR: DEXamethasone in Revision ARthroplasty

NCT02884180 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-05-23

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Dexamethasone

A dose of 24 mg dexamethasone given after start of anaesthesia

DRUG

Saline isotonic

A dose of 6 ml of isotonic saline given after start of anaesthesia

Sponsors & Collaborators

  • Daniel Hägi-Pedersen

    lead OTHER

Principal Investigators

  • Daniel Hägi-Pedersen, MD · Department of Anaesthesiology, Næstved Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-31
Primary Completion
2024-12-31
Completion
2025-03-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02884180 on ClinicalTrials.gov