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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
10/12/2019
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] 299554 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
neuroaxial anesthesia 314815 0
Condition category
Condition code
Anaesthesiology 313151 313151 0 0
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] 315807 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321680 0
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] 321680 0
before induction of spinal anesthesia
Secondary outcome [1] 375880 0
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] 375880 0
before induction of spinal anesthesia after interspinous distance assessment
Secondary outcome [2] 375881 0
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] 375881 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21924 0
Turkey
State/province [1] 21924 0
Mugla

Funding & Sponsors
Funding source category [1] 304040 0
Hospital
Name [1] 304040 0
Mugla Sitki Kocman University Training and Research Hospital
Address [1] 304040 0
Kotekli Mahalllesi Mugla Sitki Kocman University Training and Research Hospital, Anesthesiology and Reanimation Department,48001, Mugla, Turkey
Country [1] 304040 0
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] 304231 0
None
Name [1] 304231 0
Address [1] 304231 0
Country [1] 304231 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304531 0
MUGLA SITKI KOCMAN UNIVERSITY ETHICS COMMITTEE
Ethics committee address [1] 304531 0
Kötekli mahallesi, Mugla Sitki Kocman University Scientific Researches Ethics Committee Secretariat Mugla, 48001, Turkey
Ethics committee country [1] 304531 0
Turkey
Date submitted for ethics approval [1] 304531 0
10/09/2019
Approval date [1] 304531 0
17/09/2019
Ethics approval number [1] 304531 0

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 97286 0
Dr Melike Korkmaz Toker
Address 97286 0
Kotekli Mahallesi Mugla Sitki Kocman University Training And Research Hospital Anesthesiology and Reanimation Department, Mugla, 48001, Turkey
Country 97286 0
Turkey
Phone 97286 0
+905054747098
Fax 97286 0
Email 97286 0
meltoker@gmail.com
Contact person for public queries
Name 97287 0
Dr Melike Korkmaz Toker
Address 97287 0
Kotekli Mahallesi Mugla Sitki Kocman University Training And Research Hospital Anesthesiology and Reanimation Department, Mugla, 48001, Turkey
Country 97287 0
Turkey
Phone 97287 0
+905054747098
Fax 97287 0
Email 97287 0
meltoker@gmail.com
Contact person for scientific queries
Name 97288 0
Dr Melike Korkmaz Toker
Address 97288 0
Kotekli Mahallesi Mugla Sitki Kocman University Training And Research Hospital Anesthesiology and Reanimation Department, Mugla, 48001, Turkey
Country 97288 0
Turkey
Phone 97288 0
+905054747098
Fax 97288 0
Email 97288 0
meltoker@gmail.com

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 meltoker@gmail.com
What supporting documents are/will be available?
No other documents available
Summary results
No Results