Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000663752
Ethics application status
Approved
Date submitted
23/03/2022
Date registered
5/05/2022
Date last updated
3/04/2024
Date data sharing statement initially provided
5/05/2022
Date results information initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Magnetic resonance imaging (MRI) and ultrasound examination of anatomical structures traversed whilst inserting a lumbar epidural: a pilot study
Scientific title
Normal adult posterior lumbar anatomy concerned with epidural insertion techniques - a pilot: PLACE IT Pilot
Secondary ID [1] 306746 0
Nil Known
Universal Trial Number (UTN)
U1111-1276-1972
Trial acronym
PLACE IT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Normal posterior lumbar anatomy 325753 0
Neuraxial needle access 325845 0
Condition category
Condition code
Musculoskeletal 323090 323090 0 0
Normal musculoskeletal and cartilage development and function
Anaesthesiology 323165 323165 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Single measurement event estimated to take up to 90 minutes. The study researcher (a registered medical practitioner specialist anaesthetist) will make observations gained by clinical examination and ultrasound imaging. The aim is to gain morphometric description of features that may be traversed during needle access to the neuraxis.
Surface anatomical landmarks of the participant will be mapped before ultrasound examination of structures posterior to T12 - S1. The participant will be seated erect then in a flexed position for this.
The following MRI will take 45 minutes and will be in a supine but flexed hip position to assist flattening of the lumbar lordosis.
There will be no use of needles or placement of epidurals.
Intervention code [1] 323195 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331128 0
Amount and direction of movement of overlying skin in arms folded (hands on elbows) seated flexed as compared with seated erect (Frankfort plane & arms at sides) of the palpated centre of the C7 spinous process using surface anatomical palpation, a gentian violet pen, and a vernier calliper.
Timepoint [1] 331128 0
Once only at time of study
Primary outcome [2] 331129 0
Amount and direction of movement of overlying skin in arms folded (hands on elbows) seated flexed as compared with seated erect (Frankfort plane & arms at sides) of the palpated centre of the T1 spinous process using surface anatomical palpation, a gentian violet pen, and a vernier calliper.
Timepoint [2] 331129 0
Once only at time of study
Primary outcome [3] 331130 0
Amount and direction of movement of overlying skin in arms folded (hands on elbows) seated flexed as compared with seated erect (Frankfort plane & arms at sides) of the palpated centre of the root of scapula spines using surface anatomical palpation, a gentian violet pen, and a vernier calliper.
Timepoint [3] 331130 0
Once only at time of study.
Secondary outcome [1] 408872 0
Amount and direction of movement of overlying skin in arms folded (hands on elbows) seated flexed as compared with seated erect (Frankfort plane & arms at sides) of the palpated centre of the T3 spinous process using surface anatomical palpation, a gentian violet pen, and a vernier calliper.
Timepoint [1] 408872 0
Once only at time of study
Secondary outcome [2] 408873 0
Amount and direction of movement of overlying skin in arms folded (hands on elbows) seated flexed as compared with seated erect (Frankfort plane & arms at sides) of the palpated centre of the inferior angle of scapulae using surface anatomical palpation, a gentian violet pen, and a vernier calliper.
Timepoint [2] 408873 0
Once only at time of study
Secondary outcome [3] 408874 0
Amount and direction of movement of overlying skin in arms folded (hands on elbows) seated flexed as compared with seated erect (Frankfort plane & arms at sides) of the palpated centre of the T7 spinous process using surface anatomical palpation, a gentian violet pen, and a vernier calliper.
Timepoint [3] 408874 0
Once only at time of study
Secondary outcome [4] 408875 0
Amount and direction of movement of overlying skin in arms folded (hands on elbows) seated flexed as compared with seated erect (Frankfort plane & arms at sides) of the palpated centre of the superior iliac crests using surface anatomical palpation, a gentian violet pen, and a vernier calliper.
Timepoint [4] 408875 0
Once only at time of study
Secondary outcome [5] 408876 0
Amount and direction of movement of overlying skin in arms folded (hands on elbows) seated flexed as compared with seated erect (Frankfort plane & arms at sides) of the palpated centre of the intercristal line using surface anatomical palpation, a gentian violet pen, and a vernier calliper.
Timepoint [5] 408876 0
Once only at time of study
Secondary outcome [6] 408877 0
Amount and direction of movement of overlying skin in arms folded (hands on elbows) seated flexed as compared with seated erect (Frankfort plane & arms at sides) of the palpated centre of the T12 spinous processes using surface anatomical palpation, a gentian violet pen, and a vernier calliper.
Timepoint [6] 408877 0
Once only at time of study
Secondary outcome [7] 408878 0
Amount and direction of movement of overlying skin in arms folded (hands on elbows) seated flexed as compared with seated erect (Frankfort plane & arms at sides) of the palpated centre of the L1 spinous processes using surface anatomical palpation, a gentian violet pen, and a vernier calliper.
Timepoint [7] 408878 0
Once only at time of study
Secondary outcome [8] 408879 0
Amount and direction of movement of overlying skin in arms folded (hands on elbows) seated flexed as compared with seated erect (Frankfort plane & arms at sides) of the palpated centre of the L2 spinous processes using surface anatomical palpation, a gentian violet pen, and a vernier calliper.
Timepoint [8] 408879 0
Once only at time of study
Secondary outcome [9] 408880 0
Amount and direction of movement of overlying skin in arms folded (hands on elbows) seated flexed as compared with seated erect (Frankfort plane & arms at sides) of the palpated centre of the L3 spinous processes using surface anatomical palpation, a gentian violet pen, and a vernier calliper.
Timepoint [9] 408880 0
Once only at time of study
Secondary outcome [10] 408881 0
Amount and direction of movement of overlying skin in arms folded (hands on elbows) seated flexed as compared with seated erect (Frankfort plane & arms at sides) of the palpated centre of the L4 spinous processes using surface anatomical palpation, a gentian violet pen, and a vernier calliper.
Timepoint [10] 408881 0
Once only at time of study
Secondary outcome [11] 408882 0
Amount and direction of movement of overlying skin in arms folded (hands on elbows) seated flexed as compared with seated erect (Frankfort plane & arms at sides) of the palpated centre of the L5 spinous processes using surface anatomical palpation, a gentian violet pen, and a vernier calliper.
Timepoint [11] 408882 0
Once only at time of study
Secondary outcome [12] 408883 0
Amount and direction of movement of overlying skin in arms folded (hands on elbows) seated flexed as compared with seated erect (Frankfort plane & arms at sides) of the palpated centre of the S1 spinous processes using surface anatomical palpation, a gentian violet pen, and a vernier calliper.
Timepoint [12] 408883 0
Once only at time of study
Secondary outcome [13] 408884 0
Ultrasound image in flexed participant position to verify accuracy of surface marking of C7 or document the underlying spinous process.
Timepoint [13] 408884 0
Once only at time of study
Secondary outcome [14] 408885 0
Ultrasound image in flexed participant position to verify accuracy of surface marking of T1 or document the underlying spinous process.
Timepoint [14] 408885 0
Once only at time of study
Secondary outcome [15] 408886 0
Ultrasound image in flexed participant position to verify accuracy of surface marking of T3 or document the underlying spinous process.
Timepoint [15] 408886 0
Once only at time of study
Secondary outcome [16] 408888 0
Ultrasound image in flexed participant position to verify accuracy of surface marking of T7 or document the underlying spinous process.
Timepoint [16] 408888 0
Once only at time of study
Secondary outcome [17] 408889 0
Ultrasound image in flexed participant position to verify accuracy of surface marking of intercristal line or document disparity using a vernier calliper.
Timepoint [17] 408889 0
Once only at time of study
Secondary outcome [18] 408891 0
Record interspace or spinous process crossed by intercristal line in seated flexed participant position.
Timepoint [18] 408891 0
Once only at time of study
Secondary outcome [19] 408892 0
Ultrasound transverse midline view in seated flexed participant position of T12 and record the following composite measurements from one saved image:
Midline spinous process depth, articular process depth, facet joint separation, posterior complex depth, posterior complex thickness, posterior complex width, anterior complex depth, anterior complex thickness, and anterior complex width.
Timepoint [19] 408892 0
Once only at time of study
Secondary outcome [20] 408893 0
Ultrasound transverse midline view in seated flexed participant position of L1 and record the following composite measurements from one saved image:
Midline spinous process depth, articular process depth, facet joint separation, posterior complex depth, posterior complex thickness, posterior complex width, anterior complex depth, anterior complex thickness, and anterior complex width.
Timepoint [20] 408893 0
Once only at time of study
Secondary outcome [21] 408894 0
Ultrasound transverse midline view in seated flexed participant position of L2 and record the following composite measurements from one saved image:
Midline spinous process depth, articular process depth, facet joint separation, posterior complex depth, posterior complex thickness, posterior complex width, anterior complex depth, anterior complex thickness, and anterior complex width.
Timepoint [21] 408894 0
Once only at time of study
Secondary outcome [22] 408895 0
Ultrasound transverse midline view in seated flexed participant position of L3 and record the following composite measurements from one saved image:
Midline spinous process depth, articular process depth, facet joint separation, posterior complex depth, posterior complex thickness, posterior complex width, anterior complex depth, anterior complex thickness, and anterior complex width.
Timepoint [22] 408895 0
Once only at time of study
Secondary outcome [23] 408896 0
Ultrasound transverse midline view in seated flexed participant position of L4 and record the following composite measurements from one saved image:
Midline spinous process depth, articular process depth, facet joint separation, posterior complex depth, posterior complex thickness, posterior complex width, anterior complex depth, anterior complex thickness, and anterior complex width.
Timepoint [23] 408896 0
Once only at time of study
Secondary outcome [24] 408897 0
Ultrasound transverse midline view in seated flexed participant position of L5 and record the following composite measurements from one saved image:
Midline spinous process depth, articular process depth, facet joint separation, posterior complex depth, posterior complex thickness, posterior complex width, anterior complex depth, anterior complex thickness, and anterior complex width.
Timepoint [24] 408897 0
Once only at time of study
Secondary outcome [25] 408898 0
Ultrasound transverse midline view in seated flexed participant position of S1 and record the following composite measurements from one saved image:
Midline spinous process depth, articular process depth, facet joint separation, posterior complex depth, posterior complex thickness, posterior complex width, anterior complex depth, anterior complex thickness, and anterior complex width.
Timepoint [25] 408898 0
Once only at time of study
Secondary outcome [26] 408899 0
Ultrasound median sagittal view in flexed participant position of T12 to S1 and record composite measurements from one or more saved images:
Spinous process depth, articular process depth, posterior complex depth, posterior complex thickness, posterior complex height, anterior complex depth, anterior complex thickness, and anterior complex height.
Timepoint [26] 408899 0
Once only at time of study
Secondary outcome [27] 408900 0
Ultrasound oblique just paramedian sagittal view in flexed participant position of T12 to S1 and record composite measurements from one or more saved images:
Spinous process depth, articular process depth, posterior complex depth, posterior complex thickness, posterior complex height, anterior complex depth, anterior complex thickness, and anterior complex height.
Timepoint [27] 408900 0
Once only at time of study
Secondary outcome [28] 408903 0
The following secondary outcomes will be assessed separately:
Ultrasound oblique midline sagittal articular process view in flexed participant position of T12 to S1 and record composite measurements from one or more saved images:
Articular process depth and lamina depth.
AND
Characterise lumbar spine curvature when participant assumes an erect sitting position when viewed in profile using a meter rule as a reference.
AND
Record interspace or spinous process crossed by intercristal line in erect participant position.
Timepoint [28] 408903 0
Once only at time of study
Secondary outcome [29] 408904 0
The following secondary outcomes will be assessed separately:
Ultrasound transverse midline view in seated erect participant position of T12 to S1 and record the following composite measurements from six saved images:
Midline spinous process depth, articular process depth, facet joint separation, posterior complex depth, posterior complex thickness, posterior complex width, anterior complex depth, anterior complex thickness, and anterior complex width.
Timepoint [29] 408904 0
Once only at time of study
Secondary outcome [30] 408905 0
The following secondary outcomes will be assessed separately:
Ultrasound median sagittal view in erect seated participant position of T12 to S1 and record composite measurements from six or more saved images:
Spinous process depth, articular process depth, posterior complex depth, posterior complex thickness, posterior complex height, anterior complex depth, anterior complex thickness, and anterior complex height.
Timepoint [30] 408905 0
Once only at time of study
Secondary outcome [31] 408906 0
The following secondary outcomes will be assessed separately:
Ultrasound oblique just paramedian sagittal view in erect seated participant position of T12 to S1 and record composite measurements from six or more saved images:
Spinous process depth, articular process depth, posterior complex depth, posterior complex thickness, posterior complex height, anterior complex depth, anterior complex thickness, and anterior complex height.
Timepoint [31] 408906 0
Once only at time of study
Secondary outcome [32] 408907 0
The following secondary outcomes will be assessed separately:
Ultrasound oblique midline sagittal articular process view in erect seated participant position of T12 to S1 and record composite measurements from one or more saved images:
Articular process depth and lamina depth.
Timepoint [32] 408907 0
Once only at time of study
Secondary outcome [33] 408909 0
MRI derived spinous process axis measurements, T12 - S1 and record composite measurements from as many groups of three saved orthogonal multiplaner views as is required for complete documentation.
Spinous process depth, posterior spinous process width, posterior spinous process height, spinous process minimum width, depth of spinous process minimum width, depth of articular processes, distance between articular processes.
Timepoint [33] 408909 0
Once only at a time of the researcher's convenience but without undue delay

Eligibility
Key inclusion criteria
normal volunteer adults
Minimum age
18 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
over 20 years of age,
History of abnormal growth
History of back abnormality
History of back ache or back pain
History of treatments to back including but not limited to chiropractic or deep tissue massage
History of trauma to the back
History of elite physical performance
History of nutritional deficiency
Claustrophobia
Unable to tolerate a working MRI environment
Allergy to ultrasound gel or skin marker pens
Non- consent or withdrawal of consent
Unsuitable for MRI as set out in the Centre for Advanced Imaging (CAI) standard “MRI investigation screening form”
Pregnant

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2022
Actual
15/11/2022
Date of last participant enrolment
Anticipated
31/12/2023
Actual
30/12/2023
Date of last data collection
Anticipated
31/12/2023
Actual
31/12/2023
Sample size
Target
27
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 37120 0
4072 - University Of Queensland

Funding & Sponsors
Funding source category [1] 311082 0
University
Name [1] 311082 0
University of Queensland
Country [1] 311082 0
Australia
Primary sponsor type
University
Name
Centre for Advanced Imaging
Address
Centre for Advanced Imaging
University of Queensland
Building 57
University Drive
St Lucia, Qld, 4072
Country
Australia
Secondary sponsor category [1] 312413 0
None
Name [1] 312413 0
Address [1] 312413 0
Country [1] 312413 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310620 0
University of Queensland Human Research Ethics Committee B
Ethics committee address [1] 310620 0
The University of Queensland
St Lucia, Qld, 4072
Ethics committee country [1] 310620 0
Australia
Date submitted for ethics approval [1] 310620 0
18/01/2022
Approval date [1] 310620 0
10/02/2022
Ethics approval number [1] 310620 0
2021/HE001726

Summary
Brief summary
Aims
• To quantitatively describe details of normal lumbar interspinous ligament and interlaminar foramen anatomy.
• To define features that may influence needle access to the neuraxis.
Hypotheses
• The anterior lumbar interspinous ligament may be bilaminar with a gap corresponding to a midline gap between the opposing leaves of the ligamentum flavum.
• An anterior midline gap in the lumbar interspinous ligament contains fat.
• The lumbar interspinous ligament may have structural gaps not related to the ligamentum flavum.
• The gaps may have a size equivalent to an epidural needle orifice.
Objectives
• Derive morphometric data of posterior lumbar structures of normal adult volunteers using high-definition magnetic resonance and ultrasound imaging.
• Present quantitative description of normal posterior lumbar structures in a manner directly applicable to the midline passage of a needle into the neuraxis.
Methods
Recruit normal adult volunteers. Record demographic data then generate and record measurements pertaining to their lumbar spine using clinical examination, ultrasound scanning and high-definition magnetic resonance imaging. Generate descriptive statistical results, compare equivalent measurements derived from the different modalities, and describe in detail anatomical midline and adjacent features that may be sensed during needle passage to the neuraxis.
Trial website
Trial related presentations / publications
Public notes
Lawrence, Sue, Sturgess, David and Reutens, David (2019). The lumbar ligamentum flavum does not have two layers and is confluent with the interspinous ligament. Clinical Anatomy, 33 (7) ca.23518, 978-979. doi: 10.1002/ca.23518.

Contacts
Principal investigator
Name 118286 0
Dr Sue Lawrence
Address 118286 0
Centre for Advanced Imaging
University of Queensland
Building 57
University Drive
St Lucia, Qld, 4072
Country 118286 0
Australia
Phone 118286 0
+61 7 3365 4237
Fax 118286 0
+61 7 3365 3833
Email 118286 0
sue.lawrence@uqconnect.edu.au
Contact person for public queries
Name 118287 0
Dr Sue Lawrence
Address 118287 0
Centre for Advanced Imaging
University of Queensland
Building 57
University Drive
St Lucia, Qld, 4072
Country 118287 0
Australia
Phone 118287 0
+61 7 3365 4100
Fax 118287 0
+61 7 3365 3833
Email 118287 0
sue.lawrence@uqconnect.edu.au
Contact person for scientific queries
Name 118288 0
Dr Sue Lawrence
Address 118288 0
Centre for Advanced Imaging
University of Queensland
Building 57
University Drive
St Lucia, Qld, 4072
Country 118288 0
Australia
Phone 118288 0
+61 7 3365 4100
Fax 118288 0
+61 7 3365 3833
Email 118288 0
sue.lawrence@uqconnect.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
linear measurements, MRI *.ima files
When will data be available (start and end dates)?
from publication
and until
UQRDM and UQ eSpace curators see fit to cease supporting availability.
Available to whom?
Our data is to be classified as a mediated access dataset and will be available to verified collaborators and subject restrictions as set out for human data within the UQ eSpace and UQRDM environments.
Available for what types of analyses?
Verification of original research observation
Normal cohort for comparison
How or where can data be obtained?
Email the project lead investigator (sue.lawrence@uqconnect.edu.au) detailing your request for data sharing from UQRDM or click on the link within the UQ eSpace record (available only after creation of UQ eSpace record).
Detailed guidance may be accessed via https://guides.library.uq.edu.au/publish-a-dataset-with-uqrdm-and-uq-espace/grant-access-to-mediated-dataset


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.