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Trial registered on ANZCTR

Registration number

ACTRN12619001753145

Ethics application status

Approved

Date submitted

15/10/2019

Date registered

10/12/2019

Date last updated

8/04/2021

Date data sharing statement initially provided

10/12/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Effect of riders sitting position on the lumbar spine in patients undergoing neuroaxial anesthesia

Scientific title

Effect of riders sitting position on the interspinous distance of the lumbar spine in patients undergoing neuroaxial anesthesia: a prospective observational study

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

neuroaxial anesthesia

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

In this study we will use an ultrasound procedure to define the lumbar ultrasonoraphic distances of patients undergoing neuroaxial anesthesia. The ultrasound will be applied by anesthesist who is certified to use ultrasound. Initially, the patients will be informed to sit in a Classic Sitting Position (CSP), then to sit in a Hamstring Stretching Position (HSP) and the last to sit in a Driver Sitting Position (DSP). In CSP, the knees were in 90 degrees flexion, hip adduction, and feet were on a stool support. In HSP the knees were supported by the bed in extension. In DSP, the patients will swinging freely their knees with the knees flexed, and the hip abducted on the operating table. In all three positions, the 2-5 mHz convex ultrasonography (US) probe was placed in the longitudinal paramedian position in the sacral region to see the spinal canal 2-3 cm laterally from the midline. After the sacrum was identified as a continuous hyperechoic line, the US probe was shifted towards the gutter and the intervertebral spaces (acoustic window) and spinous processes (acoustic shadows) of the lumbar vertebrae will be visualized as a sawtooth view. Ultrasonography will be performed by the same anesthesiologist with at least 50 patients' experience in ultrasonography in neuroaxial blocks and images will be recorded. All USG images will then be evaluated by a different anesthesiologist who does not know which position the measurements have been made and the distance between the L3-L4 spinous processes (SPAM) and the distance between the skin and the ligamentum flavum (DLFM) will be measured in this intervertebral space.

Intervention code [1]

Not applicable

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in interspinous distance between L3 and L4 vertebra at three different positions as assessed by rapid ultrasound scan before induction of spinal anesthesia

Timepoint [1]

before induction of spinal anesthesia

Secondary outcome [1]

Change in skin to ligamentum flavum distance at three different positions as assessed by rapid ultrasound scan before induction of spinal anesthesia after interspinous distance assessment

Timepoint [1]

before induction of spinal anesthesia after interspinous distance assessment

Secondary outcome [2]

Change in intrathecal space at three different positions as assessed by rapid ultrasound scan before induction of spinal anesthesia after the assessment of interspinous distance and skin to ligamentum flavum distance

Timepoint [2]

before induction of spinal anesthesia after the assessment of interspinous distance and skin to ligamentum flavum distance

Eligibility

Key inclusion criteria

Patients aged between 18-65 years and with an ASA physical status I-II and undergoing neuroaxial anesthesia will be included to the study

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Subjects with a history of previous spinal surgery or trauma, significant spinal anatomical abnormalities, allergy to ultrasound gel, those whose body mass index > 30 kg/m2 or those who presented a language barrier will be excluded. Subjects who do not want to participate will be excluded.

Study design

Purpose

Screening

Duration

Cross-sectional

Selection

Convenience sample

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

12/12/2019

Actual

12/12/2019

Date of last participant enrolment

Anticipated

31/12/2019

Actual

31/12/2019

Date of last data collection

Anticipated

31/12/2019

Actual

31/12/2019

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Mugla

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Mugla Sitki Kocman University Training and Research Hospital

Address [1]

Kotekli Mahalllesi Mugla Sitki Kocman University Training and Research Hospital, Anesthesiology and Reanimation Department,48001, Mugla, Turkey

Country [1]

Turkey

Primary sponsor type

Individual

Name

MELIKE KORKMAZ TOKER

Address

Kötekli Mahallesi Mugla Sitki Kocman University Training and Research Hospital, Anesthesiology and Reanimation Department, Mugla, 48001, Turkey

Country

Turkey

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

MUGLA SITKI KOCMAN UNIVERSITY ETHICS COMMITTEE

Ethics committee address [1]

Kötekli mahallesi, Mugla Sitki Kocman University Scientific Researches Ethics Committee Secretariat Mugla, 48001, Turkey

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

10/09/2019

Approval date [1]

17/09/2019

Ethics approval number [1]

Summary

Brief summary

Our primary purpose is to compare the effect of ultrasound measurements change in interspinous distance between L3 and L4 vertebra between threee sitting position named as classic sitting position, hamstring stretch position and drivers sitting position.  After obtaining approval from the Mugla Sitki Kocman Scientific Clinical Researches Ethics Committee 90 patients, 18 to 65 years old with an American Society of Anesthesiologists physical status of I and II scheduled for neuroaxial anesthesia. The patients were first given the Classic Sitting Position (CSP), then the Hamstring Stretching Position (HSP) and the last Drivers Sitting Position (DSP). In all three positions, the 2-5 mHz convex ultrasonography  probe will be  placed in the longitudinal paramedian position in the sacral region to see the spinal canal 2-3 cm laterally from the midline. Ultrasonography will be performed by the same anesthesiologist  with at least 50 patients' experience in ultrasonography in neuroaxial blocks and images will be recorded. The distance between the L3-L4 spinous processes (SPAM), the distance between the skin and the ligamentum flavum (DLFM) and intrathecal space will be measured in this intervertebral space. The measurements will be compared in three different positions with the appropriate statistical methods.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Melike Korkmaz Toker

Address

Kotekli Mahallesi Mugla Sitki Kocman University Training And Research Hospital Anesthesiology and Reanimation Department, Mugla, 48001, Turkey

Country

Turkey

Phone

+905054747098

Fax

[email protected]

Contact person for public queries

Name

Melike Korkmaz Toker

Address

Kotekli Mahallesi Mugla Sitki Kocman University Training And Research Hospital Anesthesiology and Reanimation Department, Mugla, 48001, Turkey

Country

Turkey

Phone

+905054747098

Fax

[email protected]

Contact person for scientific queries

Name

Melike Korkmaz Toker

Address

Kotekli Mahallesi Mugla Sitki Kocman University Training And Research Hospital Anesthesiology and Reanimation Department, Mugla, 48001, Turkey

Country

Turkey

Phone

+905054747098

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All of the individual participant data collected during the trial will be shared

When will data be available (start and end dates)?

Data will be available after Februrary 2020. No end date determined

Available to whom?

Data will be available to only researchers who provide a methodologically sound proposal

Available for what types of analyses?

There is no specific type of analysis which the data would not be available

How or where can data be obtained?

Data can be obtained access to Principal Investigator Melike Korkmaz Toker with email [email protected]

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

Source	Title	Year of Publication	DOI
Embase	Rider sitting position widens lumbar intervertebral distance: a prospective observational study.	2023	https://dx.doi.org/10.1016/j.bjane.2021.03.010

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically