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

NCT03741465 | Completed

• 1 other identifier: YeditepeU
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia, Conduction

Keywords

neuraxial anesthesia positioning technique; Anatolian sitting position; sitting cross-legged position; sitting fetal position; ultrasonography; numerical rating scale

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (2)

• Comfort evaluation in the ASP via 5-point numerical rating scale (NRS)

  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)

  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.

Study Arms (2)

The SFP technique

ACTIVE COMPARATOR

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 ASP technique

EXPERIMENTAL

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

Interventions

The SFP technique PROCEDURE

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

The SFP technique

The ASP technique PROCEDURE

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

The ASP technique

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 ).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yeditepe University: lead

Study Sites (1)

Yeditepe University hospital

Istanbul, İçerenköy, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 27687365 BACKGROUND

Study Officials

• ferda kartufan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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."

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: November 15, 2018
• Study Start: June 1, 2018
• Primary Completion: September 20, 2018
• Study Completion: September 20, 2018
• Last Updated: November 16, 2018

Record last verified: 2018-11

Locations

TU (1)