NCT04244695Unknown4 期
Efficacy of Oral Corticosteroid in Controlling Pain After Total Knee Arthroplasty: A Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain level
研究概览
简要总结
To compare efficacy of oral steroid in controlling pain after TKA
详细描述
To compare pain and functional outcome for oral dexamethasone 16 mg, 8 mg and pacebo in patient undergoing unilateral primary total knee arthroplasy
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
- •Patients with osteoarthritis of the knee who undergoing unilateral TKA
- •ASA class I-III
- •Informed consent
- •Good cognitive function
排除标准
- •Uncontrolled DM (HbA1C > 7)
- •Uncontrolled HT
- •Morbid obesity (BMI > 40)
- •History of bleeding in GI tract
- •Corticosteroid used within 6 months
- •Sever liver or renal impairments
- •Studied drug allergy
研究组 & 干预措施
Dexamethasone 16 mg
Experimental
Dexamethasone (4mg) 4 tab oral once daily in the morning
干预措施: Dexamethasone Oral (Drug)
Dexamethasone 8 mg
Active Comparator
Dexamethasone (4mg) 2 tab and placebo 2 tab oral once daily in the morning
干预措施: Dexamethasone Oral (Drug)
Placebo
Placebo Comparator
Placebo 4 tab oral once daily in the morning
干预措施: Dexamethasone Oral (Drug)
结局指标
主要结局
Pain level
时间窗: 12, 24 ,36, 48, 60 and 72 hours after surgery
VAS for pain (0-100) at rest and on motion
次要结局
- nausea and vomiting(in the first 72 hours after surgery)
- Range of motion of the knee(24, 72 hours then 2, 6, 12 weeks after surgery)
- Functional outcome(2, 6,12 weeks after surgery)
- Blood sugar(At 8.00 am of 1, 2, 3 days after surgery)
- inflammatory level(At 8.00 am of 1, 2, 3 days and 2 weeks after surgery)
- Wound complications(3 months after surgery)
研究者
Supakit Kanitnate
membership
Thammasat University
研究点 (1)
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