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

Affiliated Hospital of Jiaxing University

Status: Begins enrollment in 9 months

Conditions: Sleep Disorder (Disorder)

Treatments: Device: taVNS; Procedure: SGB

Study type: Interventional

Funder types: Other

Identifiers

NCT07272954

2025-LP-777

Details and patient eligibility

About

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.

Enrollment: 136 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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136 participants in 2 patient groups

Stellate Ganglion Block（SGB）

Active Comparator group

Description:

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.

Treatment:

Procedure: SGB

transcutaneous vagus nerve stimulation（taVNS）

Experimental group

Description:

Three stimulations of transcutaneous auricular vagus nerve stimulation (taVNS) were administered to the patients

Treatment:

Device: taVNS