a Randomized Controlled Trial of Dexmedetomidine on Chronic Postoperative Pain After Breast and Thoracic Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- the pain intensity measure
研究概览
简要总结
Chronic postoperative pain (CPSP) is common symptom in patients after surgery, seriously affected the quality of life. Accumulating evidences have demonstrated dexmedetomidine can improve chronic pain. However, the prevention of dexmedetomidine on CPSP remain uncertain.
详细描述
Chronic postoperative pain (CPSP) is defined as pain persisting at least 3 months after surgery. It is most common in patients who undergoing breast or thoracic surgery. Dexmedetomidine, a adrenergic α2 agonists, can alleviate the postoperative pain 24 h after surgery. In our study, patients were randomly assigned to one of the two group to receive 0.5mg/kg/h infusion dexmedetomidine (Group D, n=57) or normal saline (Group C, n=57). The pain scales were evaluated day 1, day 2, day 3, month 3, month 6 after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have been 18 to 65 yr old, and been scheduled for breast or thoracic surgery.
排除标准
- •Patients with limitations of self-expression or visual dysfunction or having emergency surgery, a severe psychiatric illness, or chronic pain problems in the chest area for longer than 2 months before the surgery,or patients who could not provide informed consent were excluded.
- •Pregnant women and prisoners were also excluded.
研究组 & 干预措施
control group
an equal volume of saline
干预措施: saline (Drug)
dexmedetomidine
dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative
干预措施: dexmedetomidine (Drug)
结局指标
主要结局
the pain intensity measure
时间窗: 12 months
Self reported pain intensity in rest and activity will be recorded at day 1 before sugery, month 3, month 6, month 12 after sugery. The intensity of pain was measured by numeric rating scale (0=no pain, 10=worst possible pain)
次要结局
- anxiety(12 months)
- depression(12 months)
- sleep disturbance(12 months)
研究者
Jian-jun Yang
director, department of anesthesiology
Zhongda Hospital