NCT00334165已完成2 期
Auricular Acupuncture (AA) vs. Sham Acupuncture for Complementary Analgesia During Elective Total Hip Arthroplasty: a Randomized Controlled Trial
University Medicine Greifswald4 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2005年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 4
- 主要终点
- Intraoperative analgesics requirement
研究概览
简要总结
The aim is to investigate whether auricular acupuncture is superior to sham acupuncture in relief of acute pain and in reduction of analgesics in patients during total 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
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an American Society of Anesthesiologists physical status of I to III scheduled for elective hip arthroplasty because of degenerative osteoarthritis under general anesthesia.
- •Surgery time does not exceed 100 minutes.
- •Patients without previous opioid medication.
- •Patients ranged 45-85 years old.
- •Patients who have given informed consent.
排除标准
- •Pregnant or nursing females.
- •Recidivist alcoholics.
- •Local or systemic infection.
- •Age < 45 and > 85 years.
- •Surgery time more than 100 minutes.
- •Intraoperative complications (bleeding, required blood transfusion more than 4 units of packed cells , cardiovascular instability, required catecholamines).
- •Patients consumed opioid medication before surgery.
- •Patients with prosthetic or damaged cardiac valves.
- •Patients who are unable to understand the consent form.
- •History of psychiatric disease.
结局指标
主要结局
Intraoperative analgesics requirement
次要结局
未报告次要终点
研究者
研究点 (4)
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