Effect of Transauricular Vagus Nerve Stimulation on Postoperative Pain Management in Video Assisted Thoracic Surgery: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Pain Relief Rate
研究概览
简要总结
Transcutaneous auricular vagus nerve stimulation (taVNS) is a novel pain management technique that has gained popularity in recent years due to its non-invasive nature and ease of operation. Current literature has substantiated its efficacy in managing pain syndromes and chronic pain. However, there is a paucity of evidence regarding its effectiveness in treating acute postoperative pain. This project aims to explore the efficacy of taVNS in postoperative pain management, with a focus on video-assisted thoracic surgery(VATS). The investigators have designed a double-blind, single-center, randomized controlled clinical trial, planning to enroll 116 patients scheduled to undergo VATS(including segmentectomy or lobectomy) under general anesthesia at Peking Union Medical College Hospital. Participants will be divided into an intervention group (receiving taVNS) and a sham intervention group (receiving sham-taVNS), and will undergo a 2-hour intervention on the first postoperative day. The primary outcome is the pain relief rate, defined as a reduction of 15mm or 30% in the VAS (1-100mm) score immediately before and after the intervention on the first postoperative day. Secondary outcomes include: the proportion of patients with inadequate analgesia within three days after intervention; the difference in VAS scores immediately before and after the intervention on the first postoperative day; the incidence of opioid-related and taVNS-related side effects from the first to the third postoperative day after intervention; the number of effective and ineffective PCA presses (if used) from the first to the third postoperative day after intervention; the specifics and frequency of additional analgesic measures taken by patients from the first to the third postoperative day after intervention; the difference in RCSQ scores on the night of surgery and the night after intervention; and the probability of patients experiencing surgery-related pain three months after surgery. Follow-up period for this study will be three months after surgery.
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, Care Provider, 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
- •Age 18 years or older;
- •ASA classification I-III;
- •No prior taVNS treatment;
- •Scheduled to undergo VATS (including segmentectomy and lobectomy);
- •VAS ≥ 30 mm at any time on the day of surgery;
- •Patients and their families can understand the study design and are willing to cooperate and participate in the study.
排除标准
- •Psychiatric disorders or other conditions that prevent cooperation;
- •Long-term use of steroids or opioids;
- •Scheduled for bilateral VATS surgery;
- •History of thoracic surgery;
- •History of chronic pain, autoimmune diseases, or persistent infections.
- •Withdrawl Criteria:
- •Patient request;
- •Surgery cancellation or change in surgical method resulting in failure to meet inclusion criteria;
- •Severe perioperative complications and adverse events;
- •Severe intervention-related adverse events.
研究组 & 干预措施
taVNS group.
Paticipants in this arm will undergo a 2-hour intervention of taVNS on the first postoperative day.
干预措施: Transauricular Vagus Nerve Stimulation (Device)
sham-taVNS group.
Paticipants in this arm will undergo a 2-hour sham-intervention of taVNS on the first postoperative day.
干预措施: Sham Transauricular Vagus Nerve stimulation (Device)
结局指标
主要结局
Pain Relief Rate
时间窗: First postoperative day
Pain relief rate is defined as a reduction of 15mm or 30% in the VAS (Visual Analogue Scale, 1-100mm) score immediately before and after the intervention on the first postoperative day
次要结局
- The proportion of patients with inadequate analgesia within three days after intervention(Within three days after the intervention)
- The difference in VAS scores immediately before and after the intervention on the first postoperative day(First postoperative day)
- The number of effective and ineffective PCA attempts (if used) from the first to the third postoperative day after intervention(First to the third postoperative day)
- The incidence of opioid-related and taVNS-related side effects from the first to the third postoperative day after intervention(First to the third postoperative day)
- The specifics and frequency of additional analgesic measures taken by patients from the first to the third postoperative day after intervention(First to the third postoperative day)
- The difference in RCSQ scores on the night of surgery and the night after intervention(First to second postoperative day)
- The probability of patients experiencing surgery-related pain three months after surgery(Three months after surgery)