A New Neuraxial Position Technique  The Anatolian Sitting Position- Sitting Fetal Cross-legged

Study Overview
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Brief Summary
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A prosperous neuraxial anesthesia positioning ensures a raised chance of successful needle placement. The primary aim is to compare The Anatolian sitting position-ASP with The Sitting Fetal Position-SFP sonographically. Secondary aim is to compare their comfort.

Detailed Description
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Fifty participants were included to this prospective, randomized, consecutive controlled clinical study. Six parameters were evaluated in each position; subcutaneous tissue (ST), skin to spinous process (S-SP), transverse diameters of bilateral paraspinal muscles (left paraspinal muscle [LPM] and right paraspinal muscle [RPM]), interspinous gap opening (ISGO), mean of bilateral paraspinal muscles (MPM). The change of every measurement recorded via ultrasonography (USG) according to the positioning techniques (the Anatolian Sitting Position [ASP] could also be named as sitting fetal cross-legged position and the Sitting Fetal Position [SFP] which is a traditional sitting position) were also calculated. The calculations are explained briefly in primary outcomes (including the change of ASP-SFP in ST, S-SP, LPM, RPM, MPM, ISGO). Stretcher comfort (SC), position comfort (PC), lumbar comfort (LC), and abdominal comfort (AC) were evaluated by the participants with the 5-point Numerical Rating Scale (NRS).

Official Title
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The Anatolian Sitting Neuraxial Position Technique; is it Beneficial? A Prospective Clinical Comparison Trial Via Ultrasonography

Conditions
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Anesthesia, Conduction

Intervention / Treatment
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* Procedure: The SFP technique
* Procedure: The ASP technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healty and adult volunteers, must be able to do the sitting fetal cross-legged position ( ASP ), must be able to do the sitting fetal position ( SFP ). Exclusion Criteria: BMI higher than 40, Lumbar hernia, Scoliosis, History of spine surgery, History of trauma, History of lower back pain, Arthropathy {especially pelvic or knee problems}, Could not be able to do one or both of the two neuraxial position techniques.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Systematic randomization was made from 150 volunteers, and 50 participants were chosen. All 50 participants were planned to sit on the stretcher in both of the two positioning techniques sequentially (one after another). The two positioning techniques are 1) sitting fetal position- the SFP ( a traditional position ) and 2) sitting fetal cross-legged- the ASP ( a new position, named as  Anatolian sitting position). The investigator was planned to record all of the participants' anatomical measurements in both of those positioning techniques evaluated via ultrasonography. After each position participants were planned to evaluate each positioning technique's comfort by 5-point numerical rating scale from minimum 1 meaning poor to maximum 5 meaning excellent.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The SFP technique<br>In the SFP neuraxial positioning technique, fifty participants were planned to sit on the stretcher facing the wall of the sonography room and turned back to the consultant Radiologist with legs hanging freely, forearms on the lap and hand are on the knees. The position is completed with the back curved in the fetal position. Then the USG is performed by the consultant Radiology M.D. in maximum 2 hours time to each participant, and the 5-point NRS evaluation is done by each participant in maximum 30 minutes time until the study ends within 24 weeks. | Procedure: The SFP technique<br>* The USG, and the 5-point NRS evaluation in the SFP<br>|
| Experimental: The ASP technique<br>In the ASP neuraxial positioning technique, the same fifty participants were planned to sit on the same part of the stretcher facing the wall of the sonography room and turned back to the consultant Radiologist with legs crossed, forearms of the participants are on the lap and hands are on the knees, and the position is completed with the back curved in the fetal position.Then the USG is performed by the consultant Radiology M.D. in maximum 2 hours time to each participant, and the 5-point NRS evaluation is done by each participant in maximum 30 minutes time until the study ends within 24 weeks. | Procedure: The ASP technique<br>* The USG, and the 5-point NRS evaluation in the ASP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interspinous gap opening (ISGO) measurement in the ASP | the wideness measurement of the ISGO in millimeters via ultrasonography (USG) in the ASP | For the ASP technique, ISGO is measured in the first 10 minutes(mins.) time, for each participant, through study completion. | 
| Left paraspinal muscle (LPM) measurements in the ASP | the diameter measurement of the LPM in millimeters via ultrasonography in the ASP | For the ASP technique, LPM is measured in between 10mins. and 20mins. time, for each participant, through study completion. | 
| Right paraspinal muscle (RPM) measurements in the ASP | the diameter measurement of the RPM in millimeters via ultrasonography in the ASP | For the ASP technique, RPM is measured in between 20mins. and 30mins. time, for each participant, through study completion. | 
| The mean of bilateral paraspinal muscles (MPM) in the ASP | Measured by ( [LPM+RPM]/2) in millimeters in the ASP | For the ASP technique, MPM measurement is planned to be done in between 30mins. and 40mins. time, for each participant, through study completion. | 
| Subcutaneous tissue (ST) measurements in the ASP | the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography in the ASP | For the ASP technique, ST measurement is planned to be done in between 40mins. and 50mins. time, for each participant, through study completion. | 
| The skin to spinous process (S-SP) measurements in the ASP | the depth measurement of the skin to spinous process in millimeters via ultrasonography in the ASP | For the ASP technique, S-SP measurement is planned to be done in between 50mins. and 1 hour(hr.) time, for each participant, through study completion. | 
| Interspinous gap opening (ISGO) measurement in the SFP | the wideness measurement of the ISGO in millimeters via ultrasonography in the SFP | For the SFP technique, ISGO measurement is planned to be done, right after NRS evaluation of the ASP, in between 1hr.10mins. and 1hr.20mins. time, for each participant, through study completion. | 
| Left paraspinal muscle (LPM) measurements in the SFP | the diameter measurement of the LPM in millimeters via ultrasonography in the SFP | For the SFP technique, LPM measurement is planned to be done in between 1hr.20mins. and 1hr.30mins. time, for each participant, through study completion. | 
| Right paraspinal muscle (RPM) measurements in the SFP | the diameter measurement of the RPM in millimeters via ultrasonography in the SFP | For the SFP technique, RPM measurement is planned to be done in between 1hr.30mins. and 1hr.40mins. time, for each participant, through study completion. | 
| The mean of bilateral paraspinal muscles (MPM) in the SFP | Measured by ( [LPM+RPM]/2) in millimeters in the SFP | For the SFP technique, MPM measurement is planned to be done in between 1hr.40mins. and 1hr.50mins. time, for each participant, through study completion. | 
| Subcutaneous tissue (ST) measurements in the SFP | the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography in the SFP | For the SFP technique, ST measurement is planned to be done in between 1hr.50mins. and 2hrs. time, for each participant, through study completion. | 
| The skin to spinous process (S-SP) measurements in the SFP | the depth measurement of the skin to spinous process in millimeters via ultrasonography in the SFP | For the SFP technique, S-SP measurement is planned to be done in between 2hrs. and 2hr.10mins. time, for each participant, through study completion. | 
| the change of ISGO (ISGO ASP-SFP) | Measured by calculation; ([ISGO in the ASP in millimeters]-[ISGO in the SFP in millimeters]) | ISGO in the ASP is measured in the first 10mins., and ISGO in the SFP is measured in between 1hr.10 mins. and 1hr.20mins. time, through study completion. | 
| the change of LPM (LPM ASP-SFP) | Measured by calculation; ([LPM in ASP in millimeters]-[LPM in SFP in millimeters]) | LPM in the ASP is measured in between 10mins. and 20mins. time, and LPM in the SFP is measured in between 1hr.20mins and 1hr.30mins. time, through study completion. | 
| the change of RPM (RPM ASP-SFP) | Measured by calculation ([RPM in ASP in millimeters]-[RPM in SFP in millimeters]) | RPM in the ASP is measured in between 20mins. and 30mins. time, and RPM in the SFP is measured in between 1hr.30mins. and 1hr.40mins. time, through study completion. | 
| the change of MPM (MPM ASP-SFP) | Measured by calculation ([MPM in ASP in millimeters]-[MPM in SFP in millimeters]) | MPM in the ASP is measured in between 30mins. and 40mins. time, and MPM in the SFP is measured in between 1hr.40mins and 1hr.50mins. time, through study completion. | 
| the change of ST (ST ASP-SFP) | Measured by calculation ([ST in ASP in millimeters]-[ST in SFP in millimeters]) | ST in the ASP is measured in between 40mins. and 50mins. time, and in the SFP is measured in between 1hr.50mins and 2hrs. time, through study completion. | 
| the change of S-SP (S-SP ASP-SFP) | Measured by calculation ([S-SP in ASP in millimeters]-[S-SP in SFP in millimeters]) | S-SP in the ASP is measured in between 50mins. and 1hr. time, and S-SP in the SFP is measured in between 2 hrs. and 2hrs.10mins. time, through study completion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort evaluation in the ASP via 5-point numerical rating scale (NRS) | Comfort evaluation of the ASP technique is planned to be done by the participant right after USG. The 5-point NRS includes 5 scale. The minimum scale is1 means poor, 2 means fair, 3 means good, 4 means very good, and the maximum scale is 5 means excellent. | NRS measurement is planned to be done right after the ASP position in between 1hr. and 1hr.10mins. time, for each participant, through study completion. | 
| Comfort evaluation in the SFP via 5-point numerical rating scale (NRS) | Comfort evaluation of the SFP technique is planned to be done by the participant right after USG. The 5-point NRS includes 5 scale. The minimum scale is1 means poor, 2 means fair, 3 means good, 4 means very good, and the maximum scale is 5 means excellent. | NRS measurement is planned to be done right after the SFP position in between 2hrs.10mins. and 2hrs.20mins. time, for each participant, through study completion. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuraxial anesthesia positioning technique, Anatolian sitting position, sitting cross-legged position, sitting fetal position, ultrasonography, numerical rating scale