DEXRAR: DEXamethasone in Revision ARthroplasty

NCT ID: NCT02884180

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-31
• Study Completion Date: 2025-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment A

Dexamethasone 24 mg i.v. after start of anaesthesia

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

A dose of 24 mg dexamethasone given after start of anaesthesia

Treatment B

Saline isotonic i.v. after start of anaesthesia

Group Type: PLACEBO_COMPARATOR

Saline isotonic

Intervention Type: DRUG

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

Interventions

Dexamethasone

A dose of 24 mg dexamethasone given after start of anaesthesia

Intervention Type: DRUG

Saline isotonic

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Scheduled for unilateral, revision-TKA: Total and major partial revisions were included, i.e. revisions including the femoral and/or the tibial component(s).
• Age > 18
• American Society of Anesthesiologists (ASA) physical status classification system ASA 1- 3.
• Body mass index (BMI) > 18 and < 45
• Women in the fertile age (i.e. until one year after menopause) must have negative urine human chorionic gonadotropin (HCG) pregnancy test
• Patients who gave their written informed consent to participating in the trial after having fully understood the contents of the protocol and restrictions.

Exclusion Criteria

• Patients who cannot cooperate with the trial.
• Concomitant participation in another trial involving medication
• Patients who cannot understand or speak Danish.
• Patients with allergy to medicines used in the trial.
• Patients with daily use of methadone.
• Contraindications against NSAID, for example previous ulcer, heart failure, liver failure, or renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (<100 mia/L)
• Patients suffering from alcohol and/or drug abuse - based on the investigator's judgement.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daniel Hägi-Pedersen

OTHER

Sponsor Role: lead

Responsible Party

Daniel Hägi-Pedersen

Head of research, consultant

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Daniel Hägi-Pedersen, MD

Role: STUDY_CHAIR

Department of Anaesthesiology, Næstved Hospital

Locations

Næstved Hospital

Næstved, Region Sjælland, Denmark

Countries

Denmark

Other Identifiers

2016-002769-72

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SM1-DHAG-2016

Identifier Type: -

Identifier Source: org_study_id