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临床试验/NCT02356601
NCT02356601已完成不适用

Lumbar Neuraxial Ultrasound Corrrelation With MRI

The Adelaide and Meath Hospital0 个研究点目标入组 20 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
主要终点
Association between abnormal MRI and poor view in Ultrasound

研究概览

简要总结

Ultrasound is used increasingly to aid placement of neuraxial blocks. Good visibility of ligamentum duramater complex and posterior longitudinal ligament (LF, PLL) has a positive predictive value of 85% for successful neuraxial block. Dural puncture could still be feasible despite the absence of a good view, as reflected by a negative predictive value of 30%.

Poor neuraxial ultrasound view could be due to limitations of ultrasound or various other anatomical reasons which might include absent LF, calcification of ligaments, spinous process contact and presence or absence of epidural or subdural fat. This will be the first study of its kind to compare neuraxial ultrasound with MRI. The aim of this study is to look for anatomical correlation between neuraxial ultrasound and MRI at various lumbar interspinous levels and to look at factors that contribute to abnormal neuraxial imaging. Assuming the predicted abnormal ultrasound images to be around 30% and predicted abnormal MRI images to be 5%, 79 images should give a power of 0.9 and alpha 0.01 to analyse the association between the two. Sample Size Calculations were performed using statistical software R version 2.15.2

详细描述

After ethical committee approval, 20 consenting patients scheduled for MRI lumbar spine were included in the study. Patients with previous spinal surgeries or with gross spinal deformities were excluded. In all patients ultrasound scanning of the lumbar interspinous spaces was performed with curvilinear 2-5 MHz Sonosite probe. At each lumbar interspinous level (L1-2 to L5-S1) the best possible transverse and paramedian oblique sagittal view was obtained. The obtained ultrasound images were the graded based on the visibility of LF and PLL. The lumbar spine MRI images were analyzed by radiologists who were blinded to the ultrasound images. On MRI various parameters such as depth of epidural space, absence of LF, thickness of LF, characteristics of muscular and intervening fatty tissue, epidural/subdural fat thickness etc was noted. The correlation between neuraxial ultrasound images and various parameters observed in MRI was identified.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any adult having MRI lumbar spine done

排除标准

  • Patients with previous spinal surgery Gross spinal deformities BMI more than 50

结局指标

主要结局

Association between abnormal MRI and poor view in Ultrasound

时间窗: 2 hour post completion of MRI

Ultrasound images were the graded based on the visibility of Ligamentum Flavum (LF) and Posterior longitudinal ligament (PLL) as good (Both PLL and LF visible), intermediate (either LF or PLL only visible) or poor (both LF and PLL not visible. An abnormal MRI is defiined as one with any of the following - presence of fascet joint hypertrophy or non fusion of ligamentum flavum.

次要结局

未报告次要终点

研究者

发起方
The Adelaide and Meath Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Karthikeyan Kallidaikurichi Srinivasan

Specialist Registrar,Anaesthetics

The Adelaide and Meath Hospital

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