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

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Conduction
• Intervention / Treatment: Procedure: The SFP technique; Procedure: The ASP technique

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İçerenköy
    • Istanbul, İçerenköy, Turkey
      • Yeditepe University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: The SFP technique; The USG, and the 5-point NRS evaluation in the SFP
Experimental: 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.	Procedure: The ASP technique; The USG, and the 5-point NRS evaluation in the ASP

What is the study measuring?

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 is"1" 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 is"1" 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.

Collaborators and Investigators

• Sponsor: Yeditepe University
• Investigators: Principal Investigator: ferda kartufan

Publications and helpful links

General Publications

• Dimaculangan DP, Mazer JA, Maracaja-Neto LF. Sonographic evaluation of lumbar interlaminar space opening in a variety of patient body positions for optimal neuraxial anesthesia delivery. J Clin Anesth. 2016 Nov;34:159-65. doi: 10.1016/j.jclinane.2016.03.045. Epub 2016 May 6.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): September 20, 2018
• Study Completion (Actual): September 20, 2018

Study Registration Dates

• First Submitted: October 26, 2018
• First Submitted That Met QC Criteria: November 11, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): November 16, 2018
• Last Update Submitted That Met QC Criteria: November 15, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: ultrasonography; numerical rating scale; neuraxial anesthesia positioning technique; Anatolian sitting position; sitting cross-legged position; sitting fetal position
• Other Study ID Numbers: YeditepeU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No