Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Pain in Patients Undergoing Complex Spinal Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 98
- 主要终点
- Opioid consumption within 72 hours postoperatively
研究概览
简要总结
Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive, novel neuromodulation technique. Previous studies have demonstrated its safety and efficacy in chronic pain, mental disorders, and other diseases, but evidence regarding its use in acute postoperative pain remains limited. This project aims to explore the efficacy and safety of taVNS in managing acute pain after complex spinal surgery. This is a single-center, double-blind, randomized controlled clinical trial, planning to recruit 98 patients scheduled to undergo complex spinal surgery at the Second Affiliated Hospital of Zhejiang University School of Medicine. Participants will be randomly assigned to either the experimental group (taVNS stimulation) or the control group (sham stimulation). The experimental group will receive five stimulation sessions, each lasting one hour, from one day before surgery to three days after surgery. The primary outcome was opioid consumption within 72 hours postoperatively. Secondary outcomes included the maximum, minimum, and mean NRS on postoperative days 1, 2, and 3; NRS before and after each taVNS stimulation; time to first PCIA compression and number of PCA sessions within 3 days postoperatively; Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSQI), and Quality of Recovery Scale (QoR15) on postoperative day 3; time to first flatus, and first bowel movement; and the incidence of chronic pain, HADS, PSQI, and QoR15 at 3 months postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective general anesthesia for complex spinal surgeries
- •Age ≥ 18 years
- •ASA classification I-III
排除标准
- •Ulceration or infection of the auricle skin
- •Bradycardia (heart rate of < 60 beats/min） or third-degree atrioventricular block
- •Implanted cardiac pacemaker or other electronic devices
- •Mental disorders or long-term use of psychotropic medications
- •Severe hepatic and renal insufficiency
- •Unable to understand the content of the scale assessment or unable to cooperate with the scale assessment
- •Pregnant or lactating women
- •Expected reoperation during hospitalization
- •Expected to be transferred to the ICU after surgery
- •Participation in other concurrent clinical trials
研究组 & 干预措施
taVNS group
Paticipants in this arm will undergo a 60 minutes intervention of taVNS from one day before surgery to three days after surgery.
干预措施: transauricular auricular vagus nerve stimulation (Device)
sham group
Paticipants in this arm will undergo a 60 minutes sham stimulation from one day before surgery to three days after surgery.
干预措施: transauricular auricular vagus nerve stimulation (Device)
结局指标
主要结局
Opioid consumption within 72 hours postoperatively
时间窗: Within 72 hours postoperatively
Researchers will record the dosage of opioids used by participants within 72 hours after surgery and convert it into morphine equivalents.
次要结局
- Pain score(within 72 hours postoperatively)
- Hospital Anxiety and Depression Scale (HADS) within 3 months postoperatively(on the 3 months)
- Use of PCIA(Within 72 hours postoperatively)
- Pittsburgh Sleep Quality Index (PSQI) within 3 months postoperatively(on the 3 months)
- Functional recovery indicators(up to 2 weeks)
- Quality of Recovery Scale (QoR15) within 3 months postoperatively(on the 3 months)
- Incidence of chronic pain(at 3 months postoperatively)
- Length of hospital stay(up to 1 month)
- Adverse events(on the 3 months)
研究者
yu lina
Doctor
Second Affiliated Hospital, School of Medicine, Zhejiang University