High-Dose Steroid for Total Knee Arthroplasty - A Randomized Doubleblinded Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Postoperative pain after 24 hours: VAS
研究概览
简要总结
The purpose of the Study is to test a higher dose of steroids(Dexamethasone) given just prior to surgery in the setting of Fast-Track Kneesurgery with Arthroplasty and the effect on postoperative pain and postoperative inflammation.
详细描述
This study compares a new High-Dose dosage of steroids in the treatment of postoperative pain after Knee Arthroplasty in a Fast-Track setting.
The investigators compare the already used dose(medium dose) with a new high dose(HD) steroid given as an intravenous bolus after the spinal anaesthesia has been given, but before the surgery starts.
The hypothesis is that by attenuating the inflammatory response to the surgery itself by the steroid Dexamethasone, the investigators expect a reduction in postoperative pain upon ambulation 24 hours after unilateral Knee Arthroplasty.
Patients referred to Unilateral Total KneeArthroplasty because of knee-osteoarthritis on Hvidovre Hospital, Capital Region of Denmark or Vejle Hospital, South Region of Denmark are screened and offered inclusion in the study.
The two groups will be randomized and doubleblinded. One group will be treated, as the current guideline in the investigator's Orthopedic fast-track Arthroplasty center, with the medium dose of steroid (0,3 mg dexamethasone/kg bodyweight).
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)
盲法说明
All intervention drugs will be blinded by a nurse who is not a participant in the study or in the treatment of the patient in any way.
The Patient, the administrator of the drug(nurse or doctor), the assessor, the investigator and the care team will all be blinded.
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and
- •Booked for unilateral knee-arthroplasty.
- •Is able to take part in the investigation(selfreported pain and nausea/vomiting)
- •Understands Danish or English, or has a translator available.
- •Signed written consent.
排除标准
- •Insulin-dependent diabetes melitus.
- •Ongoing treatment with systemic glucocorticoids or immunosuppressing treatment(apart from inhaled glucocorticoids).
- •Pregnancy/Breastfeeding
- •Allergies for the investigational drug.
- •Daily use of opioids.
- •A pain catastrophizing scale(PCS) score of >
- •A history of schizophrenia or bipolar diseases, or patients with permanent use of antipsychotic medication.
研究组 & 干预措施
High dose Dexamethasone
An intravenous bolus dose of Dexamethasone 1 mg/kg bodyweight administered preoperatively before surgery.
干预措施: Dexamethasone (Drug)
Medium dose Dexamethasone
An intravenous bolus dose of Dexamethasone 0,3 mg/kg bodyweight administered preoperatively before surgery.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Postoperative pain after 24 hours: VAS
时间窗: 24 hours
The amount of patients with moderate postoperative pain in a 5 meter walk test 24 hours postoperatively after total knee-arthroplasty. Pain is monitored by the Visual Analog Scale(VAS) 0-100 mm, where 0 is no pain and 100 mm is the worst pain. Moderate pain is considered a VAS \>30 mm.
次要结局
- Postoperative opioid usage(7 days)
- Postoperative pain summed in the first 7 days(7 days)
- Postoperative antiemetics usage(7 days)
- The inflammatory response expressed by C-reactive protein(CRP).(2 days)
研究者
Niklas Ingemann Nielsen
Principal Investigator
Copenhagen University Hospital, Hvidovre