Analgesia by Single or Dual Acupoints Stimulation After Radical Mastectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Device: acupoint stimulation
* Device: no stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dual acupoint stimulation<br>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. | Device: acupoint stimulation<br>* Electric stimulation was given through electrode attached to acupoints<br>* Other names: transcutaneous electrical acupoint stimulation;|
| Experimental: single acupoint stimulation<br>The acupoints of single point group is bilateral Neiguan points(PC6), Electric stimulation was given through electrode attached to the acupoints. | Device: acupoint stimulation<br>* Electric stimulation was given through electrode attached to acupoints<br>* Other names: transcutaneous electrical acupoint stimulation;|
| Placebo Comparator: no stimulation<br>false stimulation group only attach electrodes without electric current. | Device: no stimulation<br>* patients were only attached electrodes without electric current<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of chronic pain six months after surgery |  | six months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| respiratory depression within 24 hours after surgery |  | 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 |  | 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 | 
| 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 3m after surgery |  | three months after surgery | 
| pain score at 6m after surgery |  | six months after surgery |