Lumbar Neuraxial Ultrasound Corrrelation With MRI

Sponsor
The Adelaide and Meath Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02356601
Collaborator
(none)
20
3

Study Details

Study Description

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, calciļ¬cation 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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Lumbar Neuraxial Ultrasound Corrrelation With MRI
    Study Start Date :
    Apr 1, 2013
    Actual Primary Completion Date :
    Jul 1, 2013
    Actual Study Completion Date :
    Jul 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Any adult having MRI lumbar spine done

    Exclusion Criteria:

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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • The Adelaide and Meath Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Karthikeyan Kallidaikurichi Srinivasan, Specialist Registrar,Anaesthetics, The Adelaide and Meath Hospital
    ClinicalTrials.gov Identifier:
    NCT02356601
    Other Study ID Numbers:
    • 2013/03/20 chairman's action
    First Posted:
    Feb 5, 2015
    Last Update Posted:
    Feb 5, 2015
    Last Verified:
    Feb 1, 2015
    Keywords provided by Karthikeyan Kallidaikurichi Srinivasan, Specialist Registrar,Anaesthetics, The Adelaide and Meath Hospital

    Study Results

    No Results Posted as of Feb 5, 2015