Effects of Ultrasound-Guided Stellate Ganglion Block and Transcutaneous Auricular Vagus Nerve Stimulation on Sleep Quality After Radical Mastectomy for Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SGB, taVNS.
- Who it may be relevant to
- Registry conditions: Sleep Disorder (Disorder). Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure SGB
Before the induction of anesthesia in the operating room, a skilled anesthesiologist performed a SGB under sterile conditions using real-time ultrasound in a blind grouping manner. The patient was positioned supine with the neck slightly rotated to the left. A linear probe (6-13 MHz) was placed on the neck to clearly visualize the carotid artery, internal jugular vein, vertebral artery, vagus nerve, thyroid gland, esophagus, scalene muscles, and the anterior scalene muscle at the C6 level. Subse - Device taVNS
Three stimulations of transcutaneous auricular vagus nerve stimulation (taVNS) were administered to the patients: ① According to the manufacturer's recommendations and previous studies \[32\], the initial adjustment required electrical stimulation to penetrate the skin barrier. The first intervention was conducted one day prior to the surgery, with an initial electrical stimulation frequency set at 30 Hz and a pulse width of 300 μs. The frequency and pulse width were adjusted based on the indivi
Primary outcome measures
- Total Sleep Time on the First Night Post-Surgery [Time frame: the First Night Post-Surgery]
Secondary outcome measures (5)
- Total sleep time from the second to the fourth night post-surgery [Time frame: the second to the fourth night post-surgery]
- Assessment of sleep quality during the first four nights postoperatively [Time frame: during the first four nights postoperatively]
- sleep quality and the incidence of sleep disturbances on the 30th postoperative day [Time frame: On the 30th postoperative day]
- The incidence of all complications and mortality within 72 hours postoperatively [Time frame: within 72 hours postoperatively]
- Quality of Recovery score at 24 hours postoperatively (QoR-15). [Time frame: at 24 hours postoperatively]
Eligibility criteria
Inclusion criteria
- aged 18-80 years who underwent radical surgery for breast cancer
- ASA I-III
Exclusion criteria
- 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;
- Patients with pain, lesions, infections, or unresolved external ear trauma in the area near the external ear;
- Patients with severe mental illness or a history of substance abuse related to analgesics or psychiatric medications;
- Patients with allergies to local anesthetics such as lidocaine or ropivacaine, as well as to general anesthetics;
- Patients and their families who refuse surgical anesthesia and those unable to complete the survey questionnaire.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07272954 · 2025-LP-777