Effects of Ultrasound-Guided Stellate Ganglion Block and Transcutaneous Auricular Vagus Nerve Stimulation on Sleep Quality After Radical Mastectomy for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 136
- 主要终点
- Total Sleep Time on the First Night Post-Surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 预防
- 盲法
- 三盲 (医护人员、研究者、结局评估者)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- aged 18-80 years who underwent radical surgery for breast cancer
- ASA I-III
排除标准
- 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.
研究组 & 干预措施
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.
干预措施: SGB (Procedure)
transcutaneous vagus nerve stimulation（taVNS）
Three stimulations of transcutaneous auricular vagus nerve stimulation (taVNS) were administered to the patients
干预措施: taVNS (Device)
结局指标
主要结局
Total Sleep Time on the First Night Post-Surgery
时间窗: the First Night Post-Surgery
Total Sleep Time Monitored by Actigraphy on the First Night Post-Surgery
次要结局
- Total sleep time from the second to the fourth night post-surgery(the second to the fourth night post-surgery)
- Quality of Recovery score at 24 hours postoperatively (QoR-15).(at 24 hours postoperatively)
- 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)
研究者
Qing-he Zhou
PHD
Affiliated Hospital of Jiaxing University
标识符
- NCT 编号
- NCT07272954
- 其他研究编号
- 2025-LP-777
日期
- 首次提交
- (10个月前)
- 首次发布
- (9个月前)
- 主要完成日期
- (3年后)
- 研究完成日期
- (3年后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否