Lumbar Neuraxial Ultrasound Corrrelation With MRI

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02356601

Enrollment

Registered

2015-02-05

Start date

2013-04-30

Completion date

2013-07-31

Last updated

2015-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ultrasound Imaging of Lumbar Spine

Keywords

MRI, Lumbar spine, Ultrasound

Brief summary

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

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Any adult having MRI lumbar spine done

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Association between abnormal MRI and poor view in Ultrasound	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.

Outcome results