Clinical trial NCT02741726: Analgesia by Single or Dual Acupoints Stimulation After Radical Mastectomy
Official title: Effect of Combined-acupoint or Single-acupoint Stimulation Before Surgery on Post Mastectomy Pain: a Multicentre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 593
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of chronic pain six months after surgery
timeFrame: six months after surgery
Secondary outcomes:
measure: Incidence of chronic pain three months after surgery
timeFrame: three months after surgery
measure: Remifentanil consumption during the surgery
timeFrame: from start of surgery to end of surgery, at an average of 2.5 hours
measure: the time to the first verbal response
timeFrame: end of the anesthetics infusion to patient's first response to verbal command,on an average of 30 minutes
measure: the time to extubation
timeFrame: end of the anesthetics infusion to extubation,on an average of 30 minutes
measure: postoperative nausea and vomiting within 24 h after surgery
timeFrame: end of surgery to 24 hours after surgery,on an average of 24 hours
measure: respiratory depression within 24 hours after surgery
timeFrame: end of surgery to 24 hours after surgery,on an average of 24 hours
measure: patients' s satisfaction scores on analgesia within 24 hours after surgery
timeFrame: end of surgery to 24 hours after surgery,on an average of 24 hours
measure: Visual Analogue Scale scores within 24 hours after surgery
timeFrame: end of surgery to 24 hours after surgery,on an average of 24 hours
measure: demand of rescue analgesics within 24 hours after surgery
timeFrame: end of surgery to 24 hours after surgery,on an average of 24 hours
measure: pain score at 3m after surgery
timeFrame: three months after surgery
measure: pain score at 6m after surgery
timeFrame: six months after surgery
Other outcomes:
Locations:
city: Chongqing
country: China
facility: First Afiliated Hospital of Chongqing Medical University
state: Chongqing
city: Zhengzhou
country: China
facility: People's hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: First Afiliated Hospital of Zhengzhou University
state: Henan
city: Xi'an
country: China
facility: Tangdu Hospital, Fourth Military Medical University
state: Shaanxi
city: Xi'an
country: China
facility: First Afiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Hailong Dong
role: STUDY_CHAIR
References:
citation: Lu Z, Wang Q, Sun X, Zhang W, Min S, Zhang J, Zhao W, Jiang J, Wang Y, Zhu Y, Zheng L, Wang Y, Guo Y, Zhang L, Wang L, Lei C, Liu T, Yang X, Zhang J, Li C, Zhang N, Dong H, Xiong L. Transcutaneous electrical acupoint stimulation before surgery reduces chronic pain after mastectomy: A randomized clinical trial. J Clin Anesth. 2021 Nov;74:110453. doi: 10.1016/j.jclinane.2021.110453. Epub 2021 Jul 13.