Study on the Preventive and Therapeutic Effects and Mechanism of Transcranial Direct Current Stimulation on Morphine-Induced Itching After Cesarean Section: A Randomized Clinical Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 104
- 主要终点
- Incidence of itching within 24 hours after surgery (defined as VAS itching score ≥1)
研究概览
简要总结
Cesarean section is the most common obstetric surgery worldwide. Epidural anesthesia has become the preferred anesthesia method for cesarean sections due to its definite analgesic effect and minimal impact on mother and baby. To ensure postoperative analgesia, intrathecal administration of morphine (the preferred opioid for obstetric intrathecal analgesia) is a routine clinical protocol, but morphine-induced postoperative pruritus is a common adverse reaction. A study targeting the cesarean section population confirmed that the incidence of pruritus after epidural morphine administration is as high as 40%-75%.Transcranial direct current stimulation (tDCS) can enhance the activity of GABAergic inhibitory interneurons in the spinal dorsal horn through the cortical-spinal descending pathway, reverse the inhibitory effect of morphine on them, and restore negative feedback regulation of itch-specific GRPR⁺ neurons; at the same time, it downregulates the phosphorylation level and membrane expression of μ-opioid receptors in the spinal dorsal horn, weakening the receptor activation efficiency of morphine. On the other hand, tDCS can reduce peripheral nerve excitability, decrease mast cell degranulation in the skin, and reduce the release of histamine and tryptase; simultaneously, it inhibits the activation of glial cells in the spinal cord/cortex, decreases the secretion of pro-inflammatory factors such as TNF-α and IL-6, and blocks the vicious cycle of 'inflammation-receptor upregulation-itch exacerbation,' thereby reducing the occurrence of itch.This study aims to explore the effect of transcranial direct current stimulation (tDCS) on the incidence of morphine-induced itching after cesarean section by inhibiting the central itch perception circuits in cesarean section patients and antagonizing the disinhibitory effects mediated by μ-opioid receptors in the spinal dorsal horn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-40 years, gestational age 37-41 weeks, singleton full-term pregnancy;
- •Planned elective or emergency cesarean section, using epidural anesthesia (0.1~0.2 mg/kg of morphine administered intrathecally during surgery);
- •American Society of Anesthesiologists (ASA) classification I-III;
- •Conscious and able to cooperate to complete scale assessments, serum sample collection, and postoperative follow-up;
- •Voluntarily participate in the study and sign the informed consent form.
排除标准
- •Presence of contraindications for tDCS (such as skull defects, intracranial metal implants, history of epilepsy, coagulation disorders);
- •Allergy to opioids or a history of severe OEI;
- •Presence of skin diseases (such as eczema, urticaria), liver diseases (cholestasis), mental disorders, or cognitive impairments;
- •Coexisting pregnancy complications (preeclampsia, gestational diabetes, autoimmune diseases);
- •Use of medications within the past week that may affect itch assessment, such as antihistamines, 5-HT3 receptor antagonists, or anti-inflammatory drugs.
研究组 & 干预措施
Case group (tDCS group)
干预措施: Transcranial direct current stimulation (Device)
结局指标
主要结局
Incidence of itching within 24 hours after surgery (defined as VAS itching score ≥1)
时间窗: 24 hours after surgery
The VAS scoring standard for the degree of itching is a tool used to assess the severity of itching. VAS stands for Visual Analog Scale. The following are the standards for VAS scoring of itching severity: 0 points: No itching. 1-3 points: Mild itching, does not affect daily life. 4-6 points: Moderate itching, somewhat affects daily life. 7-9 points: Severe itching, seriously affects daily life, requires active treatment. 10 points: Extremely severe itching, unbearable, requires immediate treatment.
次要结局
- Preoperative and postoperative 24h serum histaminelevels(24 hours before surgery and 24 hours after surgery)
- Preoperative and postoperative 24h trypsin-like enzymelevels(24 hours before surgery and 24 hours after surgery)
- Preoperative and postoperative 24h TNF-α levels(24 hours before surgery and 24 hours after surgery)
- Preoperative and postoperative 24h IL-6 levels(24 hours before surgery and 24 hours after surgery)
- Preoperative and postoperative 24h β-endorphin levels(24 hours before surgery and 24 hours after surgery)
- Preoperative and postoperative 24h gastrin-releasing peptide precursor (ProGRP) levels(24 hours before surgery and 24 hours after surgery)
研究者
Chaochao Zhong
Chief Researcher
Affiliated Hospital of Nantong University