DEXRAR: DEXamethasone in Revision ARthroplasty

Study Overview
=================
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.

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

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Saline isotonic


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

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 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Anti-emetic treatment the first 24 hours postoperatively | Consumption of ondansetron in the period 0-24 hours postoperatively | 0-24 hours postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexamethasone, Arthroplasty, Replacement, Knee, Revision