Clinical trial NCT02884180: DEXRAR: DEXamethasone in Revision ARthroplasty
Official title: DEXRAR: DEXamethasone in Revision ARthroplasty: A Randomised, Blinded, 2-group Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: Dexamethasone
Arthroplasty, Replacement, Knee
Revision
Lead sponsor: Naestved Hospital
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Morphine consumption the first 24 hours postoperatively
timeFrame: 0-24 hours postoperatively
Secondary outcomes:
measure: Pain during movement at 6 hours postoperatively (visual analogue scale)
timeFrame: 6 hours postoperatively
measure: Pain during movement at 24 hours postoperatively (visual analogue scale)
timeFrame: 24 hours postoperatively
measure: Pain at rest at 6 hours postoperatively (visual analogue scale)
timeFrame: 6 hours postoperatively
measure: Pain at rest at 24 hours postoperatively (visual analogue scale)
timeFrame: 24 hours postoperatively
measure: Timed up and go test
timeFrame: 24 hours postoperatively
measure: Adverse events
timeFrame: 0 - 24 hours postoperatively
measure: Nausea at 6 hours postoperatively (Verbal rating scale)
timeFrame: 6 hours postoperatively
measure: Nausea at 24 hours postoperatively (Verbal rating scale)
timeFrame: 24 hours postoperatively
measure: Vomiting the first 24 hours postoperatively
timeFrame: 0-24 hours postoperatively
measure: Dizziness at 6 hours postoperatively (Verbal rating scale)
timeFrame: 6 hours postoperatively
measure: Dizziness at 24 hours postoperatively (Verbal rating scale)
timeFrame: 24 hours postoperatively
measure: Sedation at 6 hours postoperatively (Verbal rating scale)
timeFrame: 6 hours postoperatively
measure: Sedation at 24 hours postoperatively (Verbal rating scale)
timeFrame: 24 hours postoperatively
measure: Anti-emetic treatment the first 24 hours postoperatively
timeFrame: 0-24 hours postoperatively
Other outcomes:
measure: Quality of sleep (Verbal rating scale)
timeFrame: 24 hours postoperatively
measure: Blood sugar level at 6 hours postoperatively
timeFrame: 6 hours postoperatively
measure: Blood sugar level at 24 hours postoperatively
timeFrame: 24 hours postoperatively
measure: Number of patients with need for antibiotic treatment and/or reoperation within 90 days
timeFrame: 0 - 90 days postoperatively
measure: Serious adverse events
timeFrame: 0-90 days postoperatively
measure: Days alive and outside hospital within 90 days after surgery
timeFrame: 0-90 days postoperatively
measure: Quality of live, function
timeFrame: Before surgery
measure: Quality of live, function
timeFrame: 6 month postoperatively
measure: Quality of live, function
timeFrame: 12 month postoperatively
measure: Quality of live, function
timeFrame: Before surgery
measure: Quality of live, function
timeFrame: 6 month postoperatively
measure: Quality of live, function
timeFrame: 12 month postoperatively
measure: Quality of live, function
timeFrame: Before surgery
measure: Quality of live, function
timeFrame: 6 month postoperatively
measure: Quality of live, function
timeFrame: 12 month postoperatively
Locations:
city: Næstved
country: Denmark
facility: Næstved Hospital
state: Region Zealand
Study officials:
affiliation: Department of Anaesthesiology, Næstved Hospital
name: Daniel Hägi-Pedersen, MD
role: STUDY_CHAIR
References: