Effect of Combined-acupoint or Single-acupoint Stimulation Before Surgery on Post Mastectomy Pain: a Multicentre Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 593
- 试验地点
- 6
- 主要终点
- Incidence of chronic pain six months after surgery
研究概览
简要总结
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.
详细描述
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled for operation of breast cancer；
- •ASA（American Society of Anesthesiologists）I-II；
- •Aged between 18 and 65；
- •Informed consented。
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: acupoint stimulation (Device)
single acupoint stimulation
The acupoints of single point group is bilateral Neiguan points(PC6), Electric stimulation was given through electrode attached to the acupoints.
干预措施: acupoint stimulation (Device)
no stimulation
false stimulation group only attach electrodes without electric current.
干预措施: no stimulation (Device)
结局指标
主要结局
Incidence of chronic pain six months after surgery
时间窗: six months after surgery
次要结局
- respiratory depression within 24 hours after surgery(end of surgery to 24 hours after surgery,on an average of 24 hours)
- Visual Analogue Scale scores within 24 hours after surgery(end of surgery to 24 hours after surgery,on an average of 24 hours)
- Incidence of chronic pain three months after surgery(three months after surgery)
- Remifentanil consumption during the surgery(from start of surgery to end of surgery, at an average of 2.5 hours)
- the time to the first verbal response(end of the anesthetics infusion to patient's first response to verbal command,on an average of 30 minutes)
- the time to extubation(end of the anesthetics infusion to extubation,on an average of 30 minutes)
- postoperative nausea and vomiting within 24 h after surgery(end of surgery to 24 hours after surgery,on an average of 24 hours)
- demand of rescue analgesics within 24 hours after surgery(end of surgery to 24 hours after surgery,on an average of 24 hours)
- pain score at 6m after surgery(six months after surgery)
- patients' s satisfaction scores on analgesia within 24 hours after surgery(end of surgery to 24 hours after surgery,on an average of 24 hours)
- pain score at 3m after surgery(three months after surgery)
研究者
Zhihong LU
Doctor
Air Force Military Medical University, China