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Analgesia by Single or Dual Acupoints Stimulation After Radical Mastectomy (ASDAS)

2019年10月14日 更新者：Zhihong LU

Effect of Combined-acupoint or Single-acupoint Stimulation Before Surgery on Post Mastectomy Pain: a Multicentre Randomised Controlled Trial

The purpose of this study is to compare the effects of dual acupoints and single acupoint transcutaneous electrical acupoint stimulation (TEAS) pretreatment on incidence of Post-Mastectomy Pain Syndrome(PMPS) in patients undergoing operation of breast cancer.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Patients were randomly assigned to three groups, receiving 30min TEAS before anesthesia respectively. The acupoints of dual point group are bilateral Neiguan points(PC6) combined with Danzhong point(RN17), single point group is bilateral Neiguan points(PC6), and the false stimulation group only attach electrodes without electric current. The frequency of TEAS is set to 2/15 Hz. Intraoperative anesthetic dosage of propofol and remifentanil was recorded. Three and six months after surgery, follow-up about chronic pain was made by telephone or face-to-face using the follow-up questionnaire. The adverse events were recorded.

研究类型

介入性

注册 (实际的)

593

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
    • Chongqing
      • Chongqing、Chongqing、中国
        • First Afiliated Hospital of Chongqing Medical University
    • Henan
      • Zhengzhou、Henan、中国、450003
        • People's Hospital of Zhengzhou University
      • Zhengzhou、Henan、中国、450052
        • First Afiliated Hospital of Zhengzhou University
    • Shaanxi
      • Xi'an、Shaanxi、中国、710032
        • Xijing Hospital, Fourth Military Medical University
      • Xi'an、Shaanxi、中国、710005
        • Tangdu Hospital, Fourth Military Medical University
      • Xi'an、Shaanxi、中国、710022
        • First Afiliated Hospital of Xi'an Jiaotong University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Scheduled for operation of breast cancer；
  • ASA（American Society of Anesthesiologists）I-II；
  • Aged between 18 and 65；
  • Informed consented。

Exclusion Criteria:

  • Suffered from the contraindication of TEAS including the local skin breakage, infection or planted with the electrophysiology device；
  • Unable to communicate and coordinate with the researcher, such as suffering from language comprehension deficits or mental diseases；
  • Certain/suspicious addiction with alcohol, analgesics or other drugs；
  • Unstable Angina or myocardial infarction occurred in 3 months; NYHA（New York Heart Association） is 3 or higher;
  • Blood pressure ≥ 180/110 mm Hg while preoperative visiting;
  • Suffered from diabetic complications including diabetic ketoacidosis, hyperosmolar coma, infection, macroangiopathy, diabetic nephropathy, retinopathy, cardiomyopathy, neuropathy and diabetic foot;
  • Severe dysfunction of liver or kidney meaning one of ALT（Alanine Transaminase）, AST（Aspartate Transaminase）, ALP（alkaline phosphatase） or TBIL（total bilirubin） is 2 times higher that normal or creatinine clearance < 30 ml/min or serum creatinine > 177umol/L;
  • Participate in the other clinical trial 3 month before the enrollment.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：dual acupoint stimulation
The acupoints of dual point group are bilateral Neiguan points(PC6) combined with Danzhong point(RN17), electric stimulation was given through electrode attached to the acupoints.
设备：acupoint stimulation
Electric stimulation was given through electrode attached to acupoints
其他名称：
  • 经皮穴位电刺激
实验性的：single acupoint stimulation
The acupoints of single point group is bilateral Neiguan points(PC6), Electric stimulation was given through electrode attached to the acupoints.
设备：acupoint stimulation
Electric stimulation was given through electrode attached to acupoints
其他名称：
  • 经皮穴位电刺激
安慰剂比较：no stimulation
false stimulation group only attach electrodes without electric current.
设备：no stimulation
patients were only attached electrodes without electric current

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Incidence of chronic pain six months after surgery
大体时间：six months after surgery
six months after surgery

次要结果测量

结果测量
大体时间
Incidence of chronic pain three months after surgery
大体时间：three months after surgery
three months after surgery
Remifentanil consumption during the surgery
大体时间：from start of surgery to end of surgery, at an average of 2.5 hours
from start of surgery to end of surgery, at an average of 2.5 hours
the time to the first verbal response
大体时间：end of the anesthetics infusion to patient's first response to verbal command,on an average of 30 minutes
end of the anesthetics infusion to patient's first response to verbal command,on an average of 30 minutes
the time to extubation
大体时间：end of the anesthetics infusion to extubation,on an average of 30 minutes
end of the anesthetics infusion to extubation,on an average of 30 minutes
postoperative nausea and vomiting within 24 h after surgery
大体时间：end of surgery to 24 hours after surgery,on an average of 24 hours
end of surgery to 24 hours after surgery,on an average of 24 hours
respiratory depression within 24 hours after surgery
大体时间：end of surgery to 24 hours after surgery,on an average of 24 hours
end of surgery to 24 hours after surgery,on an average of 24 hours
patients' s satisfaction scores on analgesia within 24 hours after surgery
大体时间：end of surgery to 24 hours after surgery,on an average of 24 hours
end of surgery to 24 hours after surgery,on an average of 24 hours
Visual Analogue Scale scores within 24 hours after surgery
大体时间：end of surgery to 24 hours after surgery,on an average of 24 hours
end of surgery to 24 hours after surgery,on an average of 24 hours
demand of rescue analgesics within 24 hours after surgery
大体时间：end of surgery to 24 hours after surgery,on an average of 24 hours
end of surgery to 24 hours after surgery,on an average of 24 hours
pain score at 3m after surgery
大体时间：three months after surgery
three months after surgery
pain score at 6m after surgery
大体时间：six months after surgery
six months after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Zhihong LU

调查人员

  • 学习椅：Hailong Dong、Air Force Military Medical University, China

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年5月25日

初级完成 (实际的)

2017年10月23日

研究完成 (实际的)

2018年10月23日

研究注册日期

首次提交

2016年4月13日

首先提交符合 QC 标准的

2016年4月13日

首次发布 (估计)

2016年4月18日

研究记录更新

最后更新发布 (实际的)

2019年10月16日

上次提交的符合 QC 标准的更新

2019年10月14日

最后验证

2019年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • XJH-A-2016-04-12

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

IPD including those about primary endpoint and secondary endpoints would be available to other researchers.

IPD 共享时间框架

the data will become available after manuscript published, for 5 years.

IPD 共享支持信息类型

  • 研究协议
  • 统计分析计划 (SAP)
  • 知情同意书 (ICF)
  • 临床研究报告（CSR）

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

acupoint stimulation的临床试验

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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