DEXRAR: DEXamethasone in Revision ARthroplasty: A Randomised, Blinded, 2-group Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Morphine consumption the first 24 hours postoperatively
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment A
Dexamethasone 24 mg i.v. after start of anaesthesia
干预措施: Dexamethasone (Drug)
Treatment B
Saline isotonic i.v. after start of anaesthesia
干预措施: Saline isotonic (Drug)
结局指标
主要结局
Morphine consumption the first 24 hours postoperatively
时间窗: 0-24 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
次要结局
- Pain at rest at 24 hours postoperatively (visual analogue scale)(24 hours postoperatively)
- Timed up and go test(24 hours postoperatively)
- Adverse events(0 - 24 hours postoperatively)
- Sedation at 24 hours postoperatively (Verbal rating scale)(24 hours postoperatively)
- Anti-emetic treatment the first 24 hours postoperatively(0-24 hours postoperatively)
- Pain during movement at 6 hours postoperatively (visual analogue scale)(6 hours postoperatively)
- Pain during movement at 24 hours postoperatively (visual analogue scale)(24 hours postoperatively)
- Pain at rest at 6 hours postoperatively (visual analogue scale)(6 hours postoperatively)
- Dizziness at 6 hours postoperatively (Verbal rating scale)(6 hours postoperatively)
- Dizziness at 24 hours postoperatively (Verbal rating scale)(24 hours postoperatively)
- Sedation at 6 hours postoperatively (Verbal rating scale)(6 hours postoperatively)
- Nausea at 6 hours postoperatively (Verbal rating scale)(6 hours postoperatively)
- Nausea at 24 hours postoperatively (Verbal rating scale)(24 hours postoperatively)
- Vomiting the first 24 hours postoperatively(0-24 hours postoperatively)
研究者
Daniel Hägi-Pedersen
Head of research, consultant
Naestved Hospital