Influence of Maternal Postioning on Spread of Local Anesthetic After Epidural Analgesia
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Skane
-
Lund、Skane、瑞典、22185
- University Hospital SUS
-
Malmo、Skane、瑞典、20502
- University Hospital SUS
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- all adult pregnant women recieiving epidural analgesia
Exclusion Criteria:
- participation refused
- inability to understand study purpose/instructions
- study postition could not be maintained for 30 min
- ineffective epidural
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：semi-recumbent
rutine positioning at the hospital today
|
|
|
实验性的：lateral position
experimental position to be evaluated against rutine
|
patients placed on their left side after epidural catheter insertion
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
unilateral analgesic effect
大体时间：evaluation of epidural effect after 30 min
|
clinical judgement: mothers pain-sensation and cold sensation test
|
evaluation of epidural effect after 30 min
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
maternal comfort and safety in regards to blood pressure and/or unexpected neurological effects from epidural analgesia
大体时间：evaluation of epidural effect after 30 min
|
clinical judgement: mothers subjective wellbeing, bloodpressure and incidence of vena cava compression, neurological deficits from epidural
|
evaluation of epidural effect after 30 min
|
|
fetal/neonatal safety measured with CTG and APGAR score
大体时间：CTG from start of study until birth, APGAR 2, 5 and 10min after birth
|
cardiotocographic changes and APGAR-score evaluation
|
CTG from start of study until birth, APGAR 2, 5 and 10min after birth
|
合作者和调查者
赞助
调查人员
- 学习椅：Carolina Samuelsson, MD, PhD、Region Skane, Head of the Department of Anesthesia and Intensive Care, University Hospital SUS
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- SUSAN-KK
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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