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临床试验/NCT00638274
NCT00638274已完成2 期

Comparison of Loss of Resistance Technique With Air Versus Saline to Identify Epidural Space for Combined Spinal Epidural Labor Analgesia

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 356 人开始时间: 2005年7月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
356
试验地点
2
主要终点
Success of Spinal Labor Analgesia From Combined Spinal Epidural

研究概览

简要总结

The purpose of this study is to determine whether there is a difference in success outcome of the combined spinal epidural labor analgesia between air versus saline when used to identify the epidural space.

详细描述

When the epidural needle is inserted initially, it is typically connected to a syringe filled with 2-3 ml or air or saline. This is used to help identify the placement of the epidural needle. Both air and saline are commonly used and it is not clear and debatable which is a better method to identify the correct placement of the needle. Some doctors like using air in the syringe because when a drop of clear fluid returned from the smaller spinal needle, it would be clear to indicate the correct space for first dose of medicine since no pre-existing fluid was used. In group Saline, 3 mL of saline will be used. In group Air, 3 mL of air will be used in the syringe during the procedure.

The medicine will be administered in the usual manner the doctor has identified the correct location for administration. The amount of pain during labor will be assessed the patient giving a number from 0 to 10 with 0 being no pain and 10 being the worst pain.

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
Single (Participant)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnant females weighing less than or equal to 250 lbs
  • Request for neuraxial labor analgesia

排除标准

  • ASA physical status greater than II

研究组 & 干预措施

Saline

Active Comparator

Saline 3 ml used to identify epidural space

干预措施: Saline (Procedure)

Air

Active Comparator

Air 3 ml used to identify epidural space

干预措施: Air (Procedure)

结局指标

主要结局

Success of Spinal Labor Analgesia From Combined Spinal Epidural

时间窗: 24 hours

Number of participants that had successful spinal labor analgesia in each group.

次要结局

  • Number of Participants With Failed Epidural Catheters(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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