Effects of tDCS and VNS on Postoperative Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Pain levels using Numerical Rating Scale
研究概览
简要总结
This study seeks to evaluate the efficacy of transcranial direct current stimulation (tDCS) and Afferent Vagus nerve simulation (VNS) in treating acute postoperative pain of patients in the post-anesthesia care unit after general surgery.
Study outcomes will include changes in pain levels and vital signs. For patients who are admitted after surgery, opioid consumption in the 24 hours after surgery and time from surgery to discharge are recorded as secondary outcomes.
Patients will be divided in the following comparison groups:
- Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS.
- Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS.
- Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS.
- Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.
详细描述
Two nonpharmacologic interventions have shown promise in treatment of chronic pain. Afferent Vagus nerve simulation (VNS) can modulate nociception, even though the exact mechanism is unclear. Clinically, it has found uses in chronic pain as well as early evidence of potential use in postoperative pain. Alternatively, transcranial direct current stimulation (tDCS) is a form of non-invasive and polarity-specific technique of modulating neuronal circuitry using a weak electric current delivered by a battery. tDCS has also been shown to modulate chronic pain and has been shown to produce EEG signatures similar to those seen in states of adequate intraoperative analgesia.
This study seeks to evaluate the efficacy of tDCS and VNS in treating acute postoperative pain of patients in the post-anesthesia care unit after general surgery by randomizing 200 subjects in 4 groups:
- Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS.
- Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS.
- Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS.
- Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.
Patient's vital signs and pain level will be obtained before the procedure and after. Patients that have to stay in hospital will also be evaluated by opioid consumption and time from surgery to discharge.
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
- Double (Participant, Investigator)
盲法说明
Patients will be assigned a Study ID that will determine the assigned procedure. At the study's completion the blind will be broken, and data will be turned over for analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years or above with the capacity to provide informed consent who are undergoing an elective surgery requiring general anesthesia
排除标准
- •cardiac bradyarrhythmia: taking beta-blockers;
- •patients with metal implants around the chest, neck, or head (e.g. implantable pacemakers and defibrillators, deep brain stimulation devices);
- •pregnancy
- •history of epilepsy or seizures.
- •patients undergoing surgical procedures involving the head, neck or spine, or those requiring the use of cardiopulmonary bypass
结局指标
主要结局
Pain levels using Numerical Rating Scale
时间窗: Immediately before the intervention and immediately after the intervention.
Numerical Rating Scale (NRS) from 0-10. 0 being no pain, and 10 being the worse pain patient has experienced.
Pain levels using the Verbal Rating Scale
时间窗: Immediately before the intervention and immediately after the intervention.
Verbal Rating Scale (VRS) distinguishing between no pain, mild pain, moderate pain, and severe pain.
次要结局
- Vital Signs: Blood pressure.(Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention.)
- Vital Signs: Heart rate(Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention.)
- Time from surgery to discharge(From the date of the patient's surgery until the day of the discharge, up to 2 month.)
- Opioid consumption(24 hours after surgery)
研究者
Paul Garcia
Associate Professor of Anesthesiology, Division Chief of Neuroanesthesia
Columbia University