Clinical trial · Interventional
Effects of Ultrasound-Guided Stellate Ganglion Block and Transcutaneous Auricular Vagus Nerve Stimulation on Sleep Quality After Radical Mastectomy for Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sleep Disorder (Disorder) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SGB | Procedure | — | UNRESOLVED |
| taVNS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Stellate Ganglion Block（SGB）
- 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.
- interventionNames
- Procedure: SGB
- type
- EXPERIMENTAL
- label
- transcutaneous vagus nerve stimulation（taVNS）
- description
- Three stimulations of transcutaneous auricular vagus nerve stimulation (taVNS) were administered to the patients
- interventionNames
- Device: taVNS
Primary outcomes (1)
- measure
- Total Sleep Time on the First Night Post-Surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available