A Prospective Observational Study Comparing Computer-Assisted Paramedian Approach Versus Conventional Midline Approach for Lumbar Puncture
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 主要终点
- Number of needle insertion attempts for successful LP
研究概览
简要总结
The goal of this clinical trial is to compare the effects of CMPAT and MAT in patients undergoing LP. Participants will be randomly assigned to either the CMPAT treatment group (group A) or the MAT treatment group (group B). Researchers will compare CMPAT treatment group and the MAT treatment group to see if the number of needle insertion attempts required for a successful LP, the puncture success rate, pain assessment in the back, head, and legs, and the occurrence of complications have different.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-99 years. Indication for lumber puncture (diagnostic lumbar puncture, analysis of cerebrospinal fluid composition, measurement of cerebrospinal fluid pressure, release of cerebrospinal fluid, lumbar cistern drain-age or intrathecal injection).
- •Body mass index between 18.5 and 35 kg/m2.
排除标准
- •Cerebral hernia or known high cerebrospinal fluid pressure prone to cerebral hernia.
- •Oral anticoagulant or antiplatelet therapy (≤3 days) or coagulation dysfunction, various factors lead to a higher risk of bleeding.
- •Active infection or prior infection at the surgical site.
- •Skin breakdown.
- •Previous spine fusion surgery.
- •Cauda equina syndrome.
- •Pregnancy or breast feeding.
- •Severe comorbid medical or psychiatric disorder.
- •Unwilling to adhere to any of the required procedures.
- •Cognitive impairment interfering with participant's ability to give full and - - informed consent or complete the baseline or follow-up assessments.
- •Survival expectation less than 1 month.
- •Moving abroad in 1 month.
研究组 & 干预措施
Computer-Assisted Paramedian Approac Technique
The L3-4 inter-laminar space will be selected as the target for puncture, and in the longitudinal direction, 1.0-1.5cm will be opened beside the upper edge of the spinous process (tip) of the lower vertebra as the entry point. The lumbar puncture needle will be inserted vertically along the axis of the anesthesia needle. The puncture path will be maintained completely perpendicular to the skin until the needle reached the PLTLF (posterior layer of the thoracolumbar fascia), where some resistance will be felt. The puncture direction is adjusted as needed. The tip of the needle will be tilted 20±10° in the sagittal direction and 15±5° inward such that the tip will point at the midpoint of the spinal canal. After the needle reaches the PLTLF, it will be further inserted 3-7 cm.
干预措施: Computer-Assisted Paramedian Approach Technique (Procedure)
Conventional Midline Approach Technique
Puncture will be performed on the posterior median line near the midpoint of the L3-4 Space of spinous process. The lumbar puncture needle will be inserted vertically along the axis of the anesthesia needle, or the tip of the needle will be tilted 15° in the sagittal direction toward the head, so that the needle path is parallel to the space of spinous process.
干预措施: Conventional Midline Approach Technique (Procedure)
结局指标
主要结局
Number of needle insertion attempts for successful LP
时间窗: 30 minutes following treatment
A successful puncture was defined as the presence of CSF outflow from the puncture needle. The number of needle insertion attempts was determined by the number of times the puncture needle was inserted into the target area.
次要结局
- Adverse events and other unintended effects(during surgery and 30 minutes,6 hours,1 days,3 days,7 days,2 weeks,4 weeks following treatment)
- LP success rate(30 minutes following treatment)
- Assessment of back, head and leg pain using the NRS(before treatment, during surgery and 30 minutes,6 hours,1 days,3 days,7 days,2 weeks,4 weeks following treatment)