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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dual acupoint stimulation | Experimental | 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. |
|
| single acupoint stimulation | Experimental | The acupoints of single point group is bilateral Neiguan points(PC6), Electric stimulation was given through electrode attached to the acupoints. |
|
| no stimulation | Placebo Comparator | false stimulation group only attach electrodes without electric current. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupoint stimulation | Device | Electric stimulation was given through electrode attached to acupoints |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of chronic pain six months after surgery | six months after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hailong Dong | Air Force Military Medical University, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Afiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34271271 | Derived | 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. |
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IPD including those about primary endpoint and secondary endpoints would be available to other researchers.
the data will become available after manuscript published, for 5 years.
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| no stimulation | Device | patients were only attached electrodes without electric current |
|
| 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 |
| People's hospital of Zhengzhou University |
| Zhengzhou |
| Henan |
| 450003 |
| China |
| First Afiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Tangdu Hospital, Fourth Military Medical University | Xi'an | Shaanxi | 710005 | China |
| First Afiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710022 | China |
| Xijing Hospital, Fourth Military Medical University | Xi'an | Shaanxi | 710032 | China |