DEXRAR: DEXamethasone in Revision ARthroplasty (DEXRAR)

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

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 Overview

• Status: Terminated
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Dexamethasone; Drug: Saline isotonic

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Region Zealand
    • Næstved, Region Zealand, Denmark, 4700
      • Næstved Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment A; Dexamethasone 24 mg i.v. after start of anaesthesia	Drug: Dexamethasone; A dose of 24 mg dexamethasone given after start of anaesthesia
Placebo Comparator: Treatment B; Saline isotonic i.v. after start of anaesthesia	Drug: Saline isotonic; A dose of 6 ml of isotonic saline given after start of anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain at rest at 6 hours postoperatively (visual analogue scale)	Pain scores (visual analogue scale (VAS)) at rest at 6 hours postoperatively. No pain = 0; worst imaginable pain = 100	6 hours postoperatively
Pain at rest at 24 hours postoperatively (visual analogue scale)	Pain scores (visual analogue scale (VAS)) at rest at 24 hours postoperatively. No pain = 0; worst imaginable pain = 100	24 hours postoperatively
Nausea at 6 hours postoperatively (Verbal rating scale)	Level of nausea at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe	6 hours postoperatively
Nausea at 24 hours postoperatively (Verbal rating scale)	Level of nausea at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe	24 hours postoperatively
Vomiting the first 24 hours postoperatively	Number of vomiting episodes (0-24 hours) measured in the periods 0-6 and 6-24 hours postoperatively	0-24 hours postoperatively
Anti-emetic treatment the first 24 hours postoperatively	Consumption of ondansetron in the period 0-24 hours postoperatively	0-24 hours postoperatively
Sedation at 6 hours postoperatively (Verbal rating scale)	Level of sedation at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe	6 hours postoperatively
Sedation at 24 hours postoperatively (Verbal rating scale)	Level of sedation at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe	24 hours postoperatively
Dizziness at 6 hours postoperatively (Verbal rating scale)	Level of dizziness at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe	6 hours postoperatively
Dizziness at 24 hours postoperatively (Verbal rating scale)	Level of dizziness at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe	24 hours postoperatively
Pain during movement at 6 hours postoperatively (visual analogue scale)	Pain scores (visual analogue scale (VAS)) with active 45 degrees flexion of the knee at 6 hours postoperatively. No pain = 0; worst imaginable pain = 100	6 hours postoperatively
Pain during movement at 24 hours postoperatively (visual analogue scale)	Pain scores (visual analogue scale (VAS)) with active 45 degrees flexion of the knee at 24 hours postoperatively. No pain = 0; worst imaginable pain = 100	24 hours postoperatively
Timed up and go test	Time in seconds, for standing up from a chair, walking 3 meters, turning around, walking back to the chair and sit down again	24 hours postoperatively
Adverse events	Number of patients with one or more adverse events in the intervention period (0-24 hours)	0 - 24 hours postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of sleep (Verbal rating scale)	Level of quality of sleep. Verbal rating scale: very bad, fairly bad, fairly good, very good	24 hours postoperatively
Blood sugar level at 6 hours postoperatively	Level of blood sugar af 6 hours postoperatively in mmol/L	6 hours postoperatively
Blood sugar level at 24 hours postoperatively	Level of blood sugar at 24 hours postoperatively in mmol/L	24 hours postoperatively
Number of patients with need for antibiotic treatment and/or reoperation within 90 days	Number of patients with need for antibiotic treatment and/or reoperation within 90 days after surgery	0 - 90 days postoperatively
Serious adverse events	Serious adverse events (SAE), including death, within 90 days after surgery defined as SAE (according to International Conference on Harmonization (ICH) - good clinical practice (GCP) - guidelines) except "prolongation of hospitalisation"	0-90 days postoperatively
Days alive and outside hospital within 90 days after surgery	Days alive and outside hospital within 90 days after surgery	0-90 days postoperatively
Quality of live, function	Oxford Knee Score (OKS) before surgery	Before surgery
Quality of live, function	Oxford Knee Score (OKS) 6 month after surgery	6 month postoperatively
Quality of live, function	Oxford Knee Score (OKS) 12 month after surgery	12 month postoperatively
Quality of live, function	EuroQol five dimensions 5 point Lipert scale (EQ-5D-5L) before surgery	Before surgery
Quality of live, function	EuroQol five dimensions 5 point Lipert scale (EQ-5D-5L) 6 month after surgery	6 month postoperatively
Quality of live, function	EuroQol five dimensions 5 point Lipert scale (EQ-5D-5L) 12 month after surgery	12 month postoperatively
Quality of live, function	Short Form 36 (SF-36) before surgery	Before surgery
Quality of live, function	Short Form 36 (SF-36) 6 month after surgery	6 month postoperatively
Quality of live, function	Short Form 36 (SF-36) 12 month after surgery	12 month postoperatively

Collaborators and Investigators

• Sponsor: Daniel Hägi-Pedersen
• Investigators: Study Chair: Daniel Hägi-Pedersen, MD, Department of Anaesthesiology, Næstved Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2017
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimated): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Dexamethasone; Revision; Arthroplasty, Replacement, Knee
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: SM1-DHAG-2016; 2016-002769-72 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No