DEXRAR: DEXamethasone in Revision ARthroplasty

NCT02884180 | Terminated Phase 4

• 2 other identifiers: SM1-DHAG-20162016-002769-72
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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

Keywords

Dexamethasone; Arthroplasty, Replacement, Knee; Revision

Outcome Measures

Primary Outcomes (1)

• Morphine consumption the first 24 hours postoperatively

  Total need for morphine for the first 24 hours postoperatively administered as both patient controlled analgesia (PCA) and supplemental morphine administered at the post-anaesthesia unit the first hour postoperatively

  0-24 hours postoperatively

Secondary Outcomes (14)

• Pain during movement at 6 hours postoperatively (visual analogue scale)

  6 hours postoperatively

• Pain during movement at 24 hours postoperatively (visual analogue scale)

  24 hours postoperatively

• Pain at rest at 6 hours postoperatively (visual analogue scale)

  6 hours postoperatively

• Pain at rest at 24 hours postoperatively (visual analogue scale)

  24 hours postoperatively

• Timed up and go test

  24 hours postoperatively

Other Outcomes (15)

• Quality of sleep (Verbal rating scale)

  24 hours postoperatively

• Blood sugar level at 6 hours postoperatively

  6 hours postoperatively

• Blood sugar level at 24 hours postoperatively

  24 hours postoperatively

Study Arms (2)

Treatment A

ACTIVE COMPARATOR

Dexamethasone 24 mg i.v. after start of anaesthesia

Drug: Dexamethasone

Treatment B

PLACEBO COMPARATOR

Saline isotonic i.v. after start of anaesthesia

Drug: Saline isotonic

Interventions

Dexamethasone DRUG

A dose of 24 mg dexamethasone given after start of anaesthesia

Treatment A

Saline isotonic DRUG

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

Treatment B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daniel Hägi-Pedersen: lead

Study Sites (1)

Næstved Hospital

Næstved, Region Sjælland, 4700, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Daniel Hägi-Pedersen, MD

  Department of Anaesthesiology, Næstved Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of research, consultant

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: August 30, 2016
• Study Start: May 31, 2017
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)