Influence of Maternal Postioning on Spread of Local Anesthetic After Epidural Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 950
- 试验地点
- 3
- 主要终点
- unilateral analgesic effect
研究概览
简要总结
The purpose of this study is to determine if a lateral positioning of the pregnant woman after epidural analgesia increases the incidence of unilateral functioning epidurals.
详细描述
Pregnant women requesting epidural analgesia will be randomized to either left lateral or semi-recumbent position for 30 minutes after the first epidural bolus-injection.
After 30 minutes, the clinical effect of the analgesia will be evaluated by an anesthesiologist if available or by a midwife if the anesthesiologist is unavailable. The study-period is concluded thereafter and further positioning is optional.
Maternal and fetal wellbeing are continuously being monitored during the study period and complications/interventions registered. APGAR and CTG results during the intervention will be registered and evaluated at a later stage.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •all adult pregnant women recieiving epidural analgesia
排除标准
- •participation refused
- •inability to understand study purpose/instructions
- •study postition could not be maintained for 30 min
- •ineffective epidural
研究组 & 干预措施
semi-recumbent
rutine positioning at the hospital today
lateral position
experimental position to be evaluated against rutine
干预措施: lateral position (Procedure)
结局指标
主要结局
unilateral analgesic effect
时间窗: evaluation of epidural effect after 30 min
clinical judgement: mothers pain-sensation and cold sensation test
次要结局
- maternal comfort and safety in regards to blood pressure and/or unexpected neurological effects from epidural analgesia(evaluation of epidural effect after 30 min)
- fetal/neonatal safety measured with CTG and APGAR score(CTG from start of study until birth, APGAR 2, 5 and 10min after birth)
研究者
Peter Bansch
Consultant Anesthetist
Region Skane