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

Y

Yeditepe University

Status

Completed

Conditions

Anesthesia, Conduction

Treatments

Procedure: The SFP technique
Procedure: The ASP technique

Study type

Interventional

Funder types

Other

Identifiers

NCT03741465
YeditepeU

Details and patient eligibility

About

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.

Full description

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).

Enrollment

50 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

50 participants in 2 patient groups

The SFP technique
Active Comparator group
Description:
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.
Treatment:
Procedure: The SFP technique
The ASP technique
Experimental group
Description:
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.
Treatment:
Procedure: The ASP technique

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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