Comparative Study of the Loading Dose Administrated Via Epidural Needle or Epidural Catheter for Labor Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- The time to onset of labor analgesia
研究概览
简要总结
Epidural anesthesia (EP) is widely used for labor analgesia. Time to onset of adequate pain relief of EP technique for labor analgesia may be 15 to 20 minutes.More rapid injection is often passible through the needle compared to catheter and could enhance the spread of medication within the epidural space.There is lack of research assessing the onset of labor analgesia with a large priming dose of local anesthetic through the epidural needle compared with the epidural catheter.
详细描述
The epidural analgesia was performed in the left lateral decubitus position at the L3-L4 or L2-L3 interspace using a 18 G Tuohy needle. The epidural space was accessed by the loss of resistance to air or saline (2ml or less) technique.
In the epidural needle group, after identification of epidural space, a dose of 3 ml of 0.1%ropivacaine with 0.3ug/ml sufentanil was given via the epidural needle ,3 minutes later labor analgesia was initiated with 15ml of 0.1 ropivacaine with 0.3ug/ml sufentanil over 30 seconds via the epidural needle, and then the catheter was inserted 3-5cm into the epidural space. In the epidural catheter group, the catheter was inserted 3-5cm into the epidural space after identification of epidural space, a dose of 3 ml of 0.1% ropivacaine with 0.3ug/ml sufentanil was given via the epidural catheter, 3minutes later labor analgesia was initiated with 15ml of 0.1%ropivacaine with 0.3ug/ml sufentanil as the same of group N.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •healthy, term (37-42 weeks' gestation),
- •nulliparous women with singleton
- •patients in active labor with a cervical dilation <5cm who planned labor analgesia
排除标准
- •any contraindication to neuraxial anesthesia,
- •body mass index>50kg/m2,
- •VAS <50mm on a 100-mm visual analog pain scales during an active contraction,
- •pregnancy-related diseases (ie, gestational hypertension, gestational diabetes, and preeclampsia),
- •the participants were in the event of an inadvertent dural puncture using the epidural needle, 6.fetal heart abnormity before labor analgesia.
结局指标
主要结局
The time to onset of labor analgesia
时间窗: 8 months
Compare time of onset of labor analgesia and adequate analgesia was defined as VAS score\<10mm in the presence of contraction.
次要结局
- VSA scores(8 months)
- number of PCEA bolus requests(8 months)
- analgesia drug ( ropivacaine) requests(8 months)