跳至主要内容
临床试验/NCT02827058
NCT02827058终止不适用

The Influence of Needle Diameter on Needle Failures and Post Dural Puncture Headache in Relation to Cesarean Section and Vaginal Delivery; a Prospective, Randomised Trial

Helse Nord-Trøndelag HF3 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
65
试验地点
3
主要终点
number of attempts until successful injection

研究概览

简要总结

The purpose of this study is to determine whether injection needle pen point type 'PP Gauge 25' should be recommended as a primary choice of needle (in stead of 'PP Gauge 27') for healthy pregnant women who at delivery (vaginal or cesarean section) get spinal anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •spinal anesthesia at delivery (vaginal delivery or cesarean section emergency grade 2-4)
  • •informed consent

排除标准

  • •chronic headache
  • •(attempt to) epidural anesthesia

研究组 & 干预措施

G25 pencil point needle

Experimental

healthy pregnant women who at (vaginal or cesarean section) delivery get spinal anesthesia administered with use of a 25 gauge pencil point needle

干预措施: G25 pencil point needle (Device)

G27 pencil point needle

Active Comparator

healthy pregnant women who at (vaginal or cesarean section) delivery get spinal anesthesia administered with use of a 27 gauge pencil point needle

干预措施: G27 pencil point needle (Device)

结局指标

主要结局

number of attempts until successful injection

时间窗: 0 (injection time before delivery)

次要结局

  • incidence of post dural puncture headache(48 hrs)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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