NCT03114449已完成不适用
Auricular Acupuncture (AA) vs. Sham AA Procedure for Pain Control After Elective Knee Arthroplasty - a Randomized Controlled Trial
University Medicine Greifswald0 个研究点目标入组 150 人开始时间: 2012年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 主要终点
- Postoperative requirement of analgesic tilidine (measured in mg)
研究概览
简要总结
Aim of the study To investigate whether auricular acupuncture (AA) will reduce postoperative pain and analgesic requirement in comparison with sham AA in patients after elective knee arthroplasty
Design Prospective randomized controlled blinded clinical trial
Participants:
- Patients < 80 und > 50 years old
- scheduled for knee arthroplasty under general anesthesia with < 120 minutes duration
- Without previous opioid medication
- Able to give informed consent
Outcome measures
- Postoperative analgesic requirement
- Incidence of side effects
- Physiological parameters
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 80 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 knee arthroplasty under general anesthesia
- •Surgery time does not exceed 120 minutes
- •Patients without previous opioid medication
- •Patients ranged 50-80 years old
- •Patients who have given written informed consent
排除标准
- •Recidivist alcoholics
- •Local auricular skin infection
- •Age < 50 and > 80 years
- •Surgery time more than 120 minutes
- •Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines)
- •Patients who consumed opioid medication at least 6 months before surgery
- •Patients with prosthetic or damaged cardiac valves, intracardiac and intravascular shunts, hypertrophic cardiomyopathy and mitral valve prolaps (risk of bacterial endocarditis according to guidelines of AHA)
- •Patients who are unable to understand the consent form
- •History of psychiatric disease
结局指标
主要结局
Postoperative requirement of analgesic tilidine (measured in mg)
时间窗: Six days following surgery
Requirement of opioid analgesic tilidin
次要结局
- blood pressure(12 hours following surgery)
- Patients' satisfaction with the treatment of postoperative pain using NRS-5 (where 1=excellent; 5=very bad)(12 hours following surgery)
- Side effects of analgesics(Six days following surgery)
- heart rate(12 hours after surgery)
研究者
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