Effects of Ultrasound-Guided Stellate Ganglion Block and Transcutaneous Auricular Vagus Nerve Stimulation on Sleep Quality After Radical Mastectomy for Breast Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorAffiliated Hospital of Jiaxing University

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

136 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Affiliated Hospital of Jiaxing University

Lead sponsor