About this trial
This study aims to design a prospective, randomized, controlled, dual-center, non-inferiority trial to compare the effects of ultrasound-guided sympathetic ganglion block (SGB) and transcutaneous auricular vagus nerve stimulation (taVNS) on sleep quality following radical mastectomy for breast cancer. The objective is to explore whether non-invasive neuromodulation for sleep is non-inferior to invasive neuromodulation. Participants will be randomly assigned to receive either SGB or taVNS treatment. Sleep quality will be assessed using an actigraphy device and sleep scales within four days post-surgery, and the incidence of sleep disturbances will be followed up within 30 days post-surgery.
Eligibility criteria
Qualifiers
aged 18-80 years who underwent radical surgery for breast cancer
ASA I-III
Disqualifiers
1. Patients with coagulation dysfunction;
Patients with suspected regional infection leading to severe nerve damage in the affected limb;
Patients with congenital heart disease, coronary artery disease, myocardial infarction, severe cardiac conduction block, or those with implanted cardiac pacemakers;
Patients with severe neurological disorders such as cerebral infarction, cerebral hemorrhage, or stroke;
Trial design
Treatments tested in this trial
- SGB
- taVNS
Treatment groups
Locations
Sponsors and collaborators
Affiliated Hospital of Jiaxing University
Lead sponsor