The Role of Transcranial Direct Current Stimulation in Reduction of Pain and Postoperative Opioids Consumption After Spine Surgery, Double Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- the total consumption of morphine administered by patients during the first two days postoperative
研究概览
简要总结
The experience of pain derives from changes in brain excitability. Therefore, modulating the excitability of cortical areas involved in pain processing may become an attractive option in the context of multimodal analgesia during the postoperative period.
详细描述
The combination of analgesic drugs acting on different mechanisms can potentiate the effects of analgesia. Moreover, the understanding of pain physiology at the molecular level supports the development of new specific drugs. Indeed, new neurophysiological models of pain processing by the brain are becoming exquisitely refined and are supported by electrophysiological and functional brain imaging studies. One of the interesting concepts that stemmed from these studies is the evidence that the experience of pain is reflected in the central nervous system by widespread activations and excitability changes within a network of interconnected cortical areas and subcortical structures. The network processing of noxious information and their limbic and emotional consequences has been termed the "pain matrix." The continuous observation of the activity and excitability changes that parallel the pain experience led to the development of a new therapeutic approach: the use of central nervous system stimulation techniques.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to give informed consent to participate in the study.
- •postoperative spine surgery patients(discectomy and/or laminectomy).
- •American society of anesthesiology scores I to II patients.
排除标准
- •the participant who has any history of:
- •an adverse reaction to brain stimulation.
- •a seizure
- •an unexplained loss of consciousness
- •serious head injury
- •surgery to their head
- •any brain related, neurological illnesses
- •any illness that may have caused brain injury
- •frequent or severe headaches
- •metal in your head (outside the mouth) such as shrapnel, surgical clips, or fragments from welding
- •any implanted medical devices such as cardiac pacemaker's or medical pumps
- •taking any analgesic medications in the past 24 hours
- •pregnancy
- •anyone in your family has epilepsy
研究组 & 干预措施
tDCS sham motor cortex
25 participants will have sham stimulation for 20 minutes using transcranial direct current stimulation device.
干预措施: tDCS sham motor cortex (Device)
active prefrontal cortex stimulation
25 participants will have active stimulation targeting the left dorsolateral prefrontal cortex for 20 minutes using transcranial direct current stimulation device.
干预措施: active prefrontal cortex stimulation (Device)
Active motor cortex stimulation
25 participants will have active stimulation targeting the left motor cortex for 20 minutes using transcranial direct current stimulation device.
干预措施: active motor cortex stimulation (Device)
结局指标
主要结局
the total consumption of morphine administered by patients during the first two days postoperative
时间窗: 48 hours postoperative
the investigator will calculate the amount of morphine used during the first two days postoperative.
次要结局
- Pain severity assessment using visual analogue scale (VAS score from 0-10)(30 minutes after every sessions and at the third day)
- HADS score(before surgery and at the third day)
研究者
Saeid Metwaly Abouelyazid Elsawy
Assistant lecturer
Assiut University