NCT02488291已完成不适用
Effect of 0.5µg/ml Sufentanil and Ropivacaine Towards Pregnant Women and Fetus in Analgesia Labor
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- VAS(visual analog pain score)
研究概览
简要总结
The investigators study the efficacy of epidural sufentanil/ropivacaine for analgesia labor in primiparas so as to decrease perinatal complications of analgesia labor.
详细描述
A prospective study of 120 full-term parturients receiving labor analgesia were randomly assigned into 2 groups: the 0.5Sufen group (N=60), the 0.25Sufen group (N=60).
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 (Investigator)
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients had regular prenatal examinations at the outpatient clinic;
- •They were between 25 to 35 years of age)
- •They had a gestational age ≥37 weeks and < 42 weeks;
- •They had an estimated fetal weight ≥ 2,500 g and < 4,200 g.
排除标准
- •a history of spinal surgery,
- •platelet count <100×109 /L ,
- •coagulation disorder,
- •sensorimotor disorder of lower extremity,
- •leg pain,
- •puncture point infection,
- •heart disease history,
- •pulmonary disease,
- •liver and renal function disorder and
- •a history of neuropsychiatry drugs.
研究组 & 干预措施
0.5 sufentanil
Experimental
0.5µg/ml sufentanil, 0.1% ropivacaine for 6ml/h
干预措施: 0.5µg/ml sufentanil (Drug)
0.5 sufentanil
Experimental
0.5µg/ml sufentanil, 0.1% ropivacaine for 6ml/h
干预措施: 0.1% ropivacaine (Drug)
0.25 sufentanil
Experimental
0.25µg/ml sufentanil, 0.1% ropivacaine for 6ml/h
干预措施: 0.25 sufentanil (Drug)
0.25 sufentanil
Experimental
0.25µg/ml sufentanil, 0.1% ropivacaine for 6ml/h
干预措施: 0.1% ropivacaine (Drug)
结局指标
主要结局
VAS(visual analog pain score)
时间窗: 1 year
comparison with two groups
次要结局
未报告次要终点
研究者
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