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

NCT07272954 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2025-12-09

No results posted yet for this study

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)

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. 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.

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 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

Sponsors & Collaborators

  • Affiliated Hospital of Jiaxing University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2026-12-01
Completion
2029-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07272954 on ClinicalTrials.gov