Lumbar Neuraxial Ultrasound Corrrelation With MRI

February 2, 2015 updated by: Karthikeyan Kallidaikurichi Srinivasan, The Adelaide and Meath Hospital

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients having MRI lumbar spine done

Description

Inclusion Criteria:

Any adult having MRI lumbar spine done

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between abnormal MRI and poor view in Ultrasound
Time Frame: 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.
2 hour post completion of MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Adelaide and Meath Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

February 2, 2015

First Submitted That Met QC Criteria

February 2, 2015

First Posted (Estimate)

February 5, 2015

Study Record Updates

Last Update Posted (Estimate)

February 5, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013/03/20 chairman's action

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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