Analgesic Effect of Perioperative Escitalopram for Patients With High Preoperative Level of Pain Catastrophising in Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Pain
研究概览
简要总结
Pain is a major problem after TKA, especially in patients with high pain catastrophizing. Newer MR-scan studies indicate that Escitalopram may have an immediate cognitive and emotional effect. The investigators therefore investigate the effect of Escitalopram as a perioperative analgesic.
详细描述
Pain is a major problem after TKA, especially in patients with high pain catastrophizing. Newer MR-scan studies indicate that Escitalopram may have an immediate cognitive and emotional effect. Patients with high pain catastrophizing are mentally vulnerable and may be sensitive to the effects of Escitalopram.
We therefore investigate the effect of Escitalopram as a perioperative analgesic in this group of patients where the pain problem is pronounced.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary, unilateral total knee arthroplasty (TKA)
- •Age > 18 > 81
- •Ethnic Danes
- •Score > 20 on Pain Catastrophising Scale
排除标准
- •Medication that causes risk in combination with SSRI (6 month)
- •Treatment for anxiety or depression
- •History of depression or mania
- •Treatment with systemic glucocorticoids (6 month)
- •Treatment with opioids (4 weeks)
- •Alcohol or drug abuse
- •History of malignancy
- •Fertile woman
- •History of epilepsia
- •Treatment with anticoagulants
- •BMI > 40
- •Disease affecting central or peripheral nerve function
- •History of gastrointestinal bleeding
- •History of hepato- or renal insufficiency
- •Allergy to Escitalopram
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Escitalopram
干预措施: Escitalopram (Drug)
结局指标
主要结局
Pain
时间窗: At 24 hour
Pain during walking at 24 hour after surgery
次要结局
- Pain(1 week)
- Cumulated pain scores(1 week)
- Amount of rescue analgesic(1 week)
- Side effects(1 week)
- Escitalopram level in blood-sample(48 hours)
- anxiety, depression, and sleep quality(1 week)
研究者
Troels Haxholdt Lunn
MD, PHD
Hvidovre University Hospital