DEXRAR: DEXamethasone in Revision ARthroplasty

Phase 4TerminatedNCT02884180

Daniel Hägi-Pedersen98 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pain, Postoperative

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 0-24 hours postoperatively

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 24 hours postoperatively

Adverse events

Number of patients with one or more adverse events in the intervention period (0-24 hours)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 24 hours postoperatively

Anti-emetic treatment the first 24 hours postoperatively

Consumption of ondansetron in the period 0-24 hours postoperatively

Time frame: 0-24 hours postoperatively

DEXRAR: DEXamethasone in Revision ARthroplasty

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes