Post-Mastectomy Pain Syndrome,PMPS
Conditions
Interventions
Experimental group:The experimental group will receive active electrical stimulation to the left auricular concha, with a stimulation frequency of 30 Hz, pulse width of 250 µs, 30 seconds on/30 second
Control group:The control group will receive the same treatment regimen, with a sham stimulus applied to the left auricular pavilion through electrodes. The stimulus intensity will be adjusted using t
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years. 2. Female patients diagnosed with breast cancer, scheduled for elective radical mastectomy under general anesthesia. 3. Able to understand the study process and use of various assessment scales, and able to communicate effectively with the researchers. 4. American Society of Anesthesiologists (ASA) physical status classification of 1 to 3. 5. Voluntarily willing to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with arrhythmias that require treatment. 2. Diagnosed liver or kidney dysfunction. 3. History of breast surgery. 4. Patients with neuromuscular diseases or left-sided auricular dermatitis. 5. History of opioid or other substance abuse. 6. Mental health disorders (such as depressive disorder, anxiety disorder, and personality disorders), long-term use of antipsychotic medications, or drug addiction. 7. Seizure or syncope recurrence in the past 5 years. 8. History of transient ischemic attacks or cerebrovascular accidents. 9. Patients who have received vagus nerve stimulation or acupuncture treatment within 1 month prior to the study. 10. Patients currently participating in other clinical trials or those who refuse to participate. 11. Vulnerable populations, including individuals with cognitive impairment, critically ill patients, minors, pregnant women, and illiterate individuals.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of chronic pain 3 months after mastectomy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of chronic pain 6 months after mastectomy;Consumption of remifentanil;Time to first response to verbal command;Extubation time;Incidence of postoperative nausea and vomiting;Numerical Rating Scale (NRS) score;Pain Relief Satisfaction score;Patient Health Questionnaire-9 score;Vital signs;Surgical-related conditions;QOR-15 score;ta-VNS procedure-related complications;Baseline characteristics; | — |
Countries
China
Contacts
Public ContactGang Chen
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed