Ultrasonographic and Comfort Comparison of Sitting Fetal Cross-legged Position With Lateral Decubitus Fetal Position

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

2019-03-20

Study Completion Date

2019-06-25

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 "Sitting Cross-legged Fetal Position -SCF" with "Lateral Decubitus Fetal Position-LDF" anatomically via sonography.

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 were also calculated. The calculations are explained briefly in primary outcomes (including the change of SCF-LDF 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 7-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 SCF and LDF. 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 7-point numerical rating scale from minimum

1 meaning "very bad" to maximum 7 meaning "excellent."

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

The ultrasonography was made by a consultant radiologist (M.D.) 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.

Study Groups

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The LDF neuraxial positioning technique

In the LDF neuraxial positioning technique, fifty participants were planned to lay down the stretcher facing the wall of the sonography room and turned back to the consultant Radiologist. Volunteers jaw touch to chest and legs in abdominal flexion with hands 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 7-point NRS evaluation is done by each participant in maximum 30 minutes time until the study ends within 15 weeks.

Group Type ACTIVE_COMPARATOR

Anatomical intervention with USG and comfort evaluation with NRS

Intervention Type PROCEDURE

The anatomical evaluation of the two neuraxial positioning techniques sonographically and comparison of comfort with the 7-point NRS

The SCF neuraxial positioning technique

In the SCF 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 7-point NRS evaluation is done by each participant in maximum 30 minutes time until the study ends within 15 weeks.

Group Type EXPERIMENTAL

Anatomical intervention with USG and comfort evaluation with NRS

Intervention Type PROCEDURE

The anatomical evaluation of the two neuraxial positioning techniques sonographically and comparison of comfort with the 7-point NRS

Interventions

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Anatomical intervention with USG and comfort evaluation with NRS

The anatomical evaluation of the two neuraxial positioning techniques sonographically and comparison of comfort with the 7-point NRS

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* healthy and adult volunteers,
* must be able to do the sitting cross-legged fetal position ( SCF ),
* must be able to do the Lateral decubitus fetal position (LDF).

Exclusion Criteria

* 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

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes