Effects of Pre-operative Methylprednisolone (125mg iv) After Total Hip 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
- Time to fulfill discharge criteria
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 hip arthroplasty.
The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce time to fulfill discharge criteria.
详细描述
In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total hip arthroplasty is still associated with postoperative pain and delayed rehabilitation. The investigators 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 hip 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 hip 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: Methylprednisolone (Drug)
结局指标
主要结局
Time to fulfill discharge criteria
时间窗: At discharge (mean 1-2 days)
次要结局
- Hand muscle strength(24 hours)
- Sleeping quality on the visual analog scale(up to four days)
- Inflammatory response measured as CRP in blood sample(24 hours postoperatively)
- Fatigue measured on a 10 point numeric range scale(up to four days)
- Additional analgetics, antinausea agents and sleeping medicine.(up to four days)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(up to 30 days)
- Postoperative pain scores on the visual analog scale(up 30 days)
- Postoperative nausea and vomiting (PONV) on 4 point numeric range scale(up to 4 days)
研究者
Troels Haxholdt Lunn
MD
Hvidovre University Hospital