DEXRAR: DEXamethasone in Revision ARthroplasty

Daniel Hägi-Pedersen

Status and phase: Terminated; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Dexamethasone; Drug: Saline isotonic

Study type: Interventional

Funder types: Other

Identifiers

NCT02884180

2016-002769-72 (EudraCT Number)

SM1-DHAG-2016

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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98 participants in 2 patient groups, including a placebo group

Treatment A

Active Comparator group

Description:

Dexamethasone 24 mg i.v. after start of anaesthesia

Treatment:

Drug: Dexamethasone

Treatment B

Placebo Comparator group

Description:

Saline isotonic i.v. after start of anaesthesia

Treatment:

Drug: Saline isotonic