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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep Disorder (Disorder)
• Intervention / Treatment: Procedure: SGB; Device: taVNS

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingzi An; Phone Number: +8618035193080; Email: anmingzizi@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stellate Ganglion Block（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.	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.
Experimental: transcutaneous vagus nerve stimulation（taVNS）; Three stimulations of transcutaneous auricular vagus nerve stimulation (taVNS) were administered to the patients	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total sleep time from the second to the fourth night post-surgery	Total sleep time each night from the second to the fourth night post-surgery by Actigraphy	the second to the fourth night post-surgery
Assessment of sleep quality during the first four nights postoperatively	Assessment of sleep quality using the Richards-Campbell Sleep Questionnaire(RCSQ) sleep questionnaire during the first four nights postoperatively. The total score is 150 points, with the minimum score being 0 points. A higher score indicates better postoperative sleep quality.	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 Pittsburgh Sleep Quality Index (PSQI) will be used to assess subjective sleep quality and the incidence of sleep disturbances.The score ranges from 0 to 21 points, with higher scores indicating worse postoperative sleep quality.A score greater than 7 indicates the presence of sleep disturbance.	On the 30th postoperative day
The incidence of all complications and mortality within 72 hours postoperatively	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).	Quality of Recovery score at 24 hours postoperatively (QoR-15). The score ranges from 0 to 150 points, with higher scores indicating better postoperative recovery quality.	at 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Jiaxing University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: November 22, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: taVNS
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Wake Disorders
• Other Study ID Numbers: 2025-LP-777

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No