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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2018-09-20

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.

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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).

Conditions

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Anesthesia, Conduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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."

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

The ultrasonography was made by a consultant radiologist (M.D.) Although the consultant didn't know which position was for control and which was the one the study evaluates. Although investigators were trying to mask the outcomes assessor; the consultant saw the positions because there is no way to hide the sitting positions of the participants. So there is a paradox if the consultant is masked or not.

Study Groups

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The SFP technique

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.

Group Type ACTIVE_COMPARATOR

The SFP technique

Intervention Type PROCEDURE

The USG, and the 5-point NRS evaluation in the SFP

The ASP technique

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.

Group Type EXPERIMENTAL

The ASP technique

Intervention Type PROCEDURE

The USG, and the 5-point NRS evaluation in the ASP

Interventions

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The SFP technique

The USG, and the 5-point NRS evaluation in the SFP

Intervention Type PROCEDURE

The ASP technique

The USG, and the 5-point NRS evaluation in the ASP

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes