Dexamethasone Twice for Pain Treatment of Total Knee Arthroplasty - A Randomized Blinded Placebo-controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 485
- 试验地点
- 5
- 主要终点
- Cumulative usage of morphine 0-48 hours postoperatively
研究概览
简要总结
Dexamethasone twice for pain treatment after total knee arthroplasty - A Placebo-controlled, randomised, parallel 3-group multicentre trial of one and two doses of dexamethasone for postoperative treatment
详细描述
Trial name: Dexamethasone twice for pain treatment of total knee arthroplasty - A randomized blinded placebo-controlled clinical trial
Trial Acronym: DEX-2-TKA
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 total knee arthroplasty (TKA) since combinations of different analgesic treatments are used with nearly no evidence for combined analgesic efficacy. A single perioperative dose of glucocorticoid (GCC) (i.e. dexamethasone) has well established effects on postoperative nausea and vomiting, and may be beneficial for postoperative pain. A recent trial suggested that an additional postoperative dose of GCC improved postoperative pain treatment. Recent systematic reviews, sub-studies of RCTs and cohort studies of perioperative GCC raised no concern regarding serious adverse events of a single dose GCC for non-cardiac surgery. However, optimal dose, combination and regimen of perioperative GCC remains unsettled.
Objective: To establish the analgesic effect and safety of one and two consecutive days of a single dose of dexamethasone after TKA. GCC will be administered in combination with paracetamol, NSAID (ibuprofen), and local infiltration analgesia.
Intervention: The participants will be randomised in three groups: A) 24 mg dexamethasone i.v. perioperative (POD0) and 24 mg dexamethasone i.v. on the first postoperative day (POD1); B) 24 mg dexamethasone i.v. POD0 and placebo (isotonic saline) i.v. on POD1; and C) placebo i.v. on POD0 and POD1.
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, primary total knee arthroplasty
- •BMI ≥ 18.0 and ≤ 40.0
- •Negative urine HCG pregnancy test and use of anti-conception for women in the fertile age
- •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 medication used in the trial
- •Patients with daily use of high dose opioid (> oral morphine 30 mg/day or oxycodone 30 mg/day or tramadol 150 mg/day) or any use of other opioids including methadone and transdermal opioids.
- •Patients with at daily use of systemic glucocorticoids
- •Contraindications against ibuprofen or paracetamol, for example previous ulcer, known heart failure, known liver failure, or known renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (<100 bil/l); or against treatment with glucocorticoids.
- •Dysregulated diabetes (investigators judgement)
- •Patients suffering from alcohol and/or drug abuse - based on the investigator's judgement
研究组 & 干预措施
Treatment A:
24 mg dexamethasone i.v. perioperatively and 24 mg dexamethasone i.v. on the first postoperative day
干预措施: Dexamethasone (Drug)
Treatment B:
24 mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
干预措施: Dexamethasone (Drug)
Treatment B:
24 mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
干预措施: Placebos (Drug)
Placebo
Placebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day
干预措施: Placebos (Drug)
结局指标
主要结局
Cumulative usage of morphine 0-48 hours postoperatively
时间窗: 0-48 hours postoperatively
Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine 0-24 hours and oral morphine on demand 24-48 hours, and any other supplemental morphine administered postoperatively. Consumption in mg
次要结局
- VAS-pain scores (visual analogue scale (VAS))(24 and 48 hours postoperatively)
- Adverse events, patient-reported(0-48 hours postoperatively)