Effect of Epidural Saline on Duration and Spread of Subsequent Spinal Analgesia/Anesthesia Using a CSE Technique
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Highest Sensory Blockade Level to Pinprick and to Cold
研究概览
简要总结
An attempt is being made to see if by injecting a set volume of sterile saline into the epidural space during the treatment of labor pain with a combined spinal/epidural (CSE) increases the amount of pain relief obtained and makes the labor analgesia lasts longer. Subjects are in the study from the time their CSE is placed until they request additional pain medication from the spinal dose of numbing medicine wearing off.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age greater than 12 years of age
- •ASA status 1 or 2
- •cervical dilation < 6cm
排除标准
- •ASA assigned 3 or 4
- •advanced labor (> 6cm cervical dilated)
- •distorted epidural anatomy
研究组 & 干预措施
0 mls saline injected
NO SALINE INJECTED
干预措施: Sterile normal saline 0 mls (Other)
15 mls saline
15ML SALINE ADMINISTERED EPIDURALLY
干预措施: 15 mls sterile normal saline (Other)
结局指标
主要结局
Highest Sensory Blockade Level to Pinprick and to Cold
时间窗: up to 20 minutes
Onset of analgesia to recession of analgesia. Highest spread of analgesia (highest sensory level) to cold temp and pinprick, with level defined from T1 to L5, where T1 is highest =level 17 and L5 is lowest =Level 1)
次要结局
- Duration of Analgesia (Time to Request Additional Analgesia)(up 120 minutes)
- Onset of Analgesia(up to 20 minutes)
- Occurrence of Use of Vasopressors(length of labor, up to 24 hours)
- Time to Highest Sensory Block(up to 20 minutes)
- Number of Participants Who Had Occurrence of Fetal Bradycardia(length of labor, up to 24 hours)
- Number of Participants Who Had Occurrence of Maternal Hypotension(length of labor, up to 24 hours)
- Number of Participants Who Had Occurrence of Itching(length of labor, up to 24 hours)
- Time for Regression of Motor Blockade(up to 20 minutes)
- Number of Participants Who Had Occurrence of Post Dural Puncture Headache(length of labor, up to 24 hours)
- Time for 2 Dermatome Level Regression of Sensory Block(up to 20 minutes)