The Importance of Needle Size, Needle Design and Stylet Reinsertion to Prevent Post-lumbar Puncture Headache, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 主要终点
- Odds ratio for post-lumbar puncture headache (any)
研究概览
简要总结
The objectives of this study are to investigate the effects of needle design, needle size and stylet reinsertion on the risk for headache after diagnostic LP (lumbar puncture, Post-LP headache). The following needles are used in the study:
- Sprotte 25 Gauge (G) (0.5 mm) atraumatic needle with introducer
- Sprotte 22 G (0.7 mm) atraumatic needle with introducer
- Spinocan 25 G (0.5 mm) cutting needle
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participants are not informed about the allocated needle. The follow-up telephone calls (outcome assessment) are made by an assistant nurse who is unaware of randomization allocation.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing diagnostic LP during their neurological work-up at Umeå University Hospital, Sweden, from 28 May 2013 until the study is fully recruited and;
- •Willing to participate and
- •Providing informed consent
排除标准
- •Subjects unable to participate in the study follow-up
研究组 & 干预措施
Sprotte 25G needle, stylet reinserted
干预措施: Sprotte 25G needle, stylet reinserted (Device)
Sprotte 25G needle, stylet not reinserted
干预措施: Sprotte 25G needle, stylet not reinserted (Device)
Sprotte 22G needle, stylet reinserted
干预措施: Sprotte 22G needle, stylet reinserted (Device)
Sprotte 22G needle, stylet not reinserted
干预措施: Sprotte 22G needle, stylet not reinserted (Device)
Spinocan 25G needle, stylet reinserted
干预措施: Spinocan 25G needle, stylet reinserted (Device)
Spinocan 25G needle, stylet not reinserted
干预措施: Spinocan 25G needle, stylet not reinserted (Device)
结局指标
主要结局
Odds ratio for post-lumbar puncture headache (any)
时间窗: Up to 14 days after LP
Any post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).
次要结局
- Odds ratio for post-lumbar puncture headache (severe)(Up to 14 days after LP)
- Headache duration (days)(Until cessation, up to 14 days after LP)
- Proportion using analgesia(During post-lumbar puncture headache, up to 14 days after LP)
- Proportion with back pain(Up to 14 days after LP)
- Proportion on sick leave(During post-lumbar puncture headache, up to 14 days after LP)
- Proportion with radiating leg pain(Up to 14 days after LP)
- Multiplicative interactions between age (years), sex, BMI and needle visavi the outcome "any post-LP headache" in a multivariable logistic regression model(Up to 14 days after LP)
研究者
Jonatan Salzer
Principal Investigator
Region Västerbotten