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

Zhihong LU

Status: Completed

Conditions: Pain

Treatments: Device: no stimulation; Device: acupoint stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02741726

XJH-A-2016-04-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 593 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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593 participants in 3 patient groups, including a placebo group

dual acupoint stimulation

Experimental group

Description:

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.

Treatment:

Device: acupoint stimulation

single acupoint stimulation

Experimental group

Description:

The acupoints of single point group is bilateral Neiguan points(PC6), Electric stimulation was given through electrode attached to the acupoints.

Treatment:

Device: acupoint stimulation

no stimulation

Placebo Comparator group

Description:

false stimulation group only attach electrodes without electric current.

Treatment:

Device: no stimulation