Effects of Pre-operative Methylprednisolone (125mg iv) After Total Knee Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
The purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome after knee arthroplasty.
The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce pain and improve outcome.
详细描述
In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total knee arthroplasty is still associated with postoperative pain and delayed rehabilitation. We therefore decided to evaluate the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome in a well defined fast-track setup after knee arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Elective total knee arthroplasty
- •Able to speak and understand danish
- •Able to give informed consent
排除标准
- •Alcohol or medical abuse
- •Allergies to local anesthetics or methylprednisolone
- •Age < 18 years
- •Daily use of opioids or glucocorticoids
- •Pregnancy or breastfeeding (fertile women)
研究组 & 干预措施
Methylprednisolone
Methylprednisolone 125 mg iv pre-operatively
干预措施: Methylprednisolone (Drug)
Saline
Saline iv pre-operatively in equivalent volume (placebo)
干预措施: Placebo (Drug)
结局指标
主要结局
Postoperative pain
时间窗: 48 hours + follow up
次要结局
- Fatigue(48 hours + follow up)
- Postoperative nausea and vomiting (PONV)(48 hours + follow up)
- Sleeping quality(48 hours + follow up)
- Inflammatory response(48 hours + follow up)
- Additional analgetics, antinausea agents and sleeping medicine(48 hours + follow up)
- Time in hospital(Until discharge)
研究者
Troels Haxholdt Lunn
MD
Hvidovre University Hospital