← Back to all trials
Not Yet Recruiting
NCT07272954
Effects of Ultrasound-Guided Stellate Ganglion Block and Transcutaneous Auricular Vagus Nerve Stimulation on Sleep Quality After Radical Mastectomy for Breast Cancer
Conditions: Sleep Disorder (Disorder)
Sex: Female
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 136
Sponsor: Affiliated Hospital of Jiaxing University
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.
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.
Source: ClinicalTrials.gov (NCT07272954). StuddyBuddy aggregates publicly available trial information.