Should Physicians Use a 24 Gauge Spinal Needle Instead of a 22 Gauge When Performing a Lumbar Puncture ? A Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Time to collect 5 ml of CSF
研究概览
简要总结
This study is intended to help guide the choice of needle diameter when performing a lumbar puncture.
Smaller spinal needles have been shown to decrease rate of adverse events such as post-lumbar puncture headache and hearing loss.
The main drawback to using smaller needles is diminished flow rate; some textbooks recommend using needles no smaller than 22 gauge because of the slow flow rate though others recommend smaller needles, namely 22-24 gauge.
Some authors have described a successful use of spinal needles as small as 25 gauge when performing a lumbar puncture.
The investigators do not believe that the flow-rate difference between 22 and 24 gauge needles is significant enough to justify using the larger needles.
The investigators trial will compare the Whitacre 22 gauge and Whitacre 24 gauge needles for flow rate, and incidence of the known complications of pain during procedure and backache at 8 and 15 days post-procedure.
The investigators will also look at whether smaller needles are associated with less pain during the procedure and less backache the next 2 weeks after the procedure.
详细描述
The purpose of this randomized, double-blinded clinical trial is to assess whether a 24 gauge spinal needle can provide an acceptable flow rate of cerebrospinal fluid (CSF) when compared to the traditionally used 22 gauge needle.
Smaller needles, according to The Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology are 'associated with reduced frequency of post-lumbar puncture headache (Level A recommendation).'
Given that flow rate of CSF is the limiting factor when choosing a spinal needle gauge, two previous studies have compared various needle sizes for adequacy of flow. These studies, however, have important limitations and have not led to a clear consensus in clinical practice. For instance, one study used a 0,9 % solution of sodium chloride at room temperature, the other used an 'artificial CSF solution' of unknown viscosity and nature.
Patients referred to the neurological day center of the Montreal Neurological Institute/Hospital for lumbar puncture will be recruited to the study. Participants will be randomized to have the puncture with a Whitacre 22 or 24 gauge 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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients (>= 18 years old) referred at the Neurological Day Center to get a lumbar puncture
排除标准
- •Contraindication to get a lumbar puncture
研究组 & 干预措施
Whitacre 22 gauge
lumbar puncture performed with a Whitacre 22 gauge (BD)
干预措施: whitacre 22 gauge (Device)
Whitacre 24 gauge
lumbar puncture performed with a Whitacre 24 gauge (BD)
干预措施: whitacre 24 gauge (Device)
结局指标
主要结局
Time to collect 5 ml of CSF
时间窗: after 5 ml of CSF is retrieved
Time 0 will be when the first drop of CSF emerges from the needle hub. Time stops when 5 ml of CSF is retrieved (last drop dripping out of the needle hub) Volume will be confirmed by a blinded research assistant. In the event that the volume differs slightly from 5ml, the time will be adjusted accordingly to reflect collection of exactly 5ml.
次要结局
- Backache first 8 days after the lumbar puncture (LP)(Assessed at 8 days after the LP)
- Time to collect 7 ml of CSF(after 7 ml of CSF is retrieved)
- Severity of backache first 8 days after the LP(Assessed at 8 days after the LP)
- Backache first 15 days after the LP(Assessed at 15 days after the LP)
- Post-lumbar puncture headache (PLPH) at 8 days(8 days after the LP)
- Severity of the post-lumbar puncture headache (PLPH) at 15 days(15 days after the LP)
- Time to collect 9 ml of CSF(after 9 ml of CSF is retrieved)
- Time to collect 12 ml of CSF(after 12 ml of CSF is retrieved)
- Severity of backache first 15 days after the LP(Assessed at 15 days after the LP)
- Time to collect 8 ml of CSF(after 8 ml of CSF is retrieved)
- Time to collect 11 ml of CSF(after 11 ml of CSF is retrieved)
- Time to collect 13 ml of CSF(after 13 ml of CSF is retrieved)
- Pain related to LP(Immediately after LP)
- Medical attention for backache(at 15 days)
- Undifferentiated headache at 8 days(8 days after the LP)
- Time to collect 10 ml of CSF(after 10 ml of CSF is retrieved)
- Time to collect 6 ml of CSF(after 6 ml of CSF is retrieved)
- Time to collect 15 ml of CSF(after 15 ml of CSF is retrieved)
- Severity of the post-lumbar puncture headache (PLPH) at 8 days(8 days after the LP)
- Time to get CSF(During the LP)
- Extra time patients are willing to spend - part 2(8 days after LP)
- Medical attention for PLPH(at 8 days)
- Epidural blood patch for PLPH(at 15 days)
- Undifferentiated headache at 15 days(15 days after the LP)
- Post-lumbar puncture headache (PLPH) at 15 days(15 days after the LP)
- Medical treatment for backache(15 days)
- Hearing loss(15 days after LP)
- Time to collect 14 ml of CSF(after 14 ml of CSF is retrieved)
- Extra time patients are willing to spend - part 1(immediately after the LP)
- Extra time patients willing to spend - part 3(15 days after LP)
- Number of attempts(during the LP)
- Medical treatment for PLPH(15 days)
- Medical attention for PLPH(at 15 days)
- Medical attention for backache(at 8 days)
- Medical treatment for PLPH(8 days)
- Medical treatment for backache(8 days)
- Epidural blood patch for PLPH(at 8 days)
- Hearing loss(8 days after LP)
研究者
Liam Durcan
MD, FRCPc, Neurologist-in-Chief, Montreal Neurological Hospital Interim Clinical Director, Neurology, McGill University Health Center
McGill University