Acupuncture vs. Standard Therapy for Treatment of Postoperative Pain in Patients Scheduled for Arthroscopic Knee Surgery - a Pilot Non-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Analgesic requirement
研究概览
简要总结
Aim of the study: To investigate whether acupuncture with indwelling fixed needles reduces pain and analgesic requirement and foster mobilization in patients after arthroscopic knee surgery (AKS) Design: Prospective pilot investigation with non-randomized arm Number of patients: N = 60 (30 patients with acupuncture additional to standard pain treatment (SPT) vs. 30 patients with SPT only Inclusion criteria: Adult patients scheduled to elective AKS in general anaesthesia with < 80 min. duration Without previous opioid and psychotropic medication Given informed consentOutcome measures: Postoperative analgesic requirement; Pain intensity; Incidence of side effects; Physiological parameters; Mobilization score
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with an American Society of Anesthesiologists physical status of I to II scheduled for elective ambulatory arthroscopic knee surgery under standardized general anesthesia
- •Surgery time does not exceed 80 minutes
- •Patients without previous opioid and psychotropic medication
- •Patients aged between 19 and 55 years, able to fill in the study questionnaire (Appendix F)
- •Patients who have given written informed consent
排除标准
- •Current psychiatric disease
- •Local skin infection at the sites of acupuncture
- •Aged < 19 or > 55 years
- •Failure to follow the standardized schema of general anaesthesia
- •Surgery time more than 80 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 who are unable to understand the consent form or to fill in the study questionnaire.
研究组 & 干预措施
Acupuncture
30 patients will receive acupuncture additionally to standard pharmacological therapy of postoperative pain
干预措施: Acupuncture (Other)
No intervention
30 patients will receive just standard pharmacological therapy of postoperative pain
结局指标
主要结局
Analgesic requirement
时间窗: 10 days
Total dose of ibuprofen taken by the patient during 10 days after arthroscopic knee surgery
次要结局
- Pain intensity: verbal rating scale(10 days after surgery)
- Side affects(10 days after surgery)