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

NCT07272954 | Not Yet Recruiting DMC

• 1 other identifier: 2025-LP-777
• Study Type: interventional
• Target: 136
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sleep Disorder (Disorder)

Keywords

taVNS

Outcome Measures

Primary Outcomes (1)

• Total Sleep Time on the First Night Post-Surgery

  Total Sleep Time Monitored by Actigraphy on the First Night Post-Surgery

  the First Night Post-Surgery

Secondary Outcomes (5)

• Total sleep time from the second to the fourth night post-surgery

  the second to the fourth night post-surgery

• Assessment of sleep quality during the first four nights postoperatively

  during the first four nights postoperatively

• sleep quality and the incidence of sleep disturbances on the 30th postoperative day

  On the 30th postoperative day

• The incidence of all complications and mortality within 72 hours postoperatively

  within 72 hours postoperatively

• Quality of Recovery score at 24 hours postoperatively (QoR-15).

  at 24 hours postoperatively

Study Arms (2)

Stellate Ganglion Block（SGB）

ACTIVE COMPARATOR

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.

Procedure: SGB

transcutaneous vagus nerve stimulation（taVNS）

EXPERIMENTAL

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

Device: taVNS

Interventions

SGB PROCEDURE

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. Subsequently, a 48mm, 20-gauge needle was inserted in a "plane" direction into the prevertebral fascia of the anterior scalene muscle. After the needle tip penetrated the prevertebral fascia and negative pressure aspiration was confirmed, 3ml of 0.5% ropivacaine was injected, and the diffusion of the local anesthetic was observed under ultrasound guidance.

Stellate Ganglion Block（SGB）

taVNS DEVICE

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 individual patient's sensations until the maximum tolerable current stimulation was reached without discomfort, lasting for 30 minutes; ② The second intervention occurred immediately after the patient was connected to the monitoring equipment in the operating room, once their vital signs were confirmed to be within normal ranges. The same stimulation frequency as the first intervention was applied for 30 minutes; ③ The third intervention was administered in the recovery room after the patient's surgery

transcutaneous vagus nerve stimulation（taVNS）

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18-80 years who underwent radical surgery for breast cancer
• ASA I-III

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Affiliated Hospital of Jiaxing University: lead

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Mingzi An

CONTACT

+8618035193080; anmingzizi@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 9, 2025
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL