Comparison of the Impact Between Minimally Invasive and Traditional Spinal Anesthesia for Cesarean Section in Maternal Anticoagulation Therapy:Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Visual analogue score of post-dural puncture headache
研究概览
简要总结
Spinal canal anesthesia is marked the most commonly used method of cesarean section. Traditional spinal anesthesia may cause post-dural puncture headache and low back pain.Plenty of parturients are undergoing anticoagulation therapy.They may be forced to accept general anesthesia in order to avoid epidural hematoma.Therefore, we propose minimally invasive spinal anesthesia.
详细描述
Traditional group patients will receive cutting type 22 gauge needles, while minimally invasive group patients will receive pen type 27 gauge needles.Patients will be blinded to the intervention allocations. Spinal anesthesia will be performed with a standardized technique. Lumbar puncture will be performed through an interspace (L3-4 or L2-3) with patients in a lateral decubitus position. After free flow of cerebrospinal fluid through the needle tip be verified, 2ml ropivacaine will be injected. We will record puncture situation, anesthesia plane and measure post-dural puncture headache, post-operative back pain and epidural hematoma.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •puerpera accept anticoagulation therapy
- •American society of anesthesiologists(ASA) classification I to II level
- •Willing to participate in this study and signed an informed consent
- •pregnancy at least 37 weeks
排除标准
- •platelet count less than 50*100000000
- •International Normalized Ratio more than 1.5
- •site of puncture with infection
- •with intracranial hypertension
- •with lumbar spine or spinal cord disorders
结局指标
主要结局
Visual analogue score of post-dural puncture headache
时间窗: 1 to 7 days after operation
次要结局
- Visual analogue score of low back pain(1 to 7 days after operation)