NCT02102815已完成4 期
Efficacy of Preoperative Intravenous Dexamethasone in Controlling Postoperative Pain After Primary Total Knee Arthroplasty: A Randomized Double-blinded Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- post-operative pain
研究概览
简要总结
To determine efficacy of preoperative IV dexamethasone for postoperative pain control after TKA.
详细描述
Preoperative intravenous over 0.1 mg/kg of dexamethasone could be reduced pain after primary TKA.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
- •50-85 years old
- •ASA class 1-3
排除标准
- •Unable to perform spinal anaesthesia
- •History of drug allergies: steroids
- •Renal impairment (CrCl <30 mL/min)
- •Liver impairment
- •Cognitive function disorders
- •Poor controlled DM (HA1C > 7.5)
- •Morning DTX at operative day > 180 mg%
- •Received corticosteroids within 3 months before surgery
研究组 & 干预措施
Dexamethasone
Experimental
Preoperative dexamethasone 0.15mg/Kg mixed with NSS to 50 mL IV slowly push over 5 minutes
干预措施: Dexamethasone (Drug)
Placebo
Placebo Comparator
Preoperative intravenous normal saline 50 mL slowly push over 5 minutes
干预措施: Normal saline (Drug)
结局指标
主要结局
post-operative pain
时间窗: 48 hours
measured with VAS for pain, drugs for relief pain
次要结局
- Functional knee score(3 month)
- post-operative nausea and vomiting(48 hours)
- complication of preoperative dexamethasone(2 weeks)
- inflammatory level(48 hours)
研究者
Supakit Kanitnate
Orthopaedics department
Thammasat University
研究点 (1)
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