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Completed

NCT Number: NCT03741465

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

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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Key information

Conditions

Anesthesia, Conduction

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yeditepe University hospital

Istanbul, İçerenköy, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The SFP technique

Procedure

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

The ASP technique

Procedure

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

Primary outcomes

  1. Interspinous gap opening (ISGO) measurement in the ASP

    Time frame: For the ASP technique, ISGO is measured in the first 10 minutes(mins.) time, for each participant, through study completion.

    the wideness measurement of the ISGO in millimeters via ultrasonography (USG) in the ASP

  2. Left paraspinal muscle (LPM) measurements in the ASP

    Time frame: For the ASP technique, LPM is measured in between 10mins. and 20mins. time, for each participant, through study completion.

    the diameter measurement of the LPM in millimeters via ultrasonography in the ASP

  3. Right paraspinal muscle (RPM) measurements in the ASP

    Time frame: For the ASP technique, RPM is measured in between 20mins. and 30mins. time, for each participant, through study completion.

    the diameter measurement of the RPM in millimeters via ultrasonography in the ASP

  4. The mean of bilateral paraspinal muscles (MPM) in the ASP

    Time frame: For the ASP technique, MPM measurement is planned to be done in between 30mins. and 40mins. time, for each participant, through study completion.

    Measured by ( [LPM+RPM]/2) in millimeters in the ASP

  5. Subcutaneous tissue (ST) measurements in the ASP

    Time frame: For the ASP technique, ST measurement is planned to be done in between 40mins. and 50mins. time, for each participant, through study completion.

    the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography in the ASP

  6. The skin to spinous process (S-SP) measurements in the ASP

    Time frame: 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.

    the depth measurement of the skin to spinous process in millimeters via ultrasonography in the ASP

  7. Interspinous gap opening (ISGO) measurement in the SFP

    Time frame: 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.

    the wideness measurement of the ISGO in millimeters via ultrasonography in the SFP

  8. Left paraspinal muscle (LPM) measurements in the SFP

    Time frame: 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.

    the diameter measurement of the LPM in millimeters via ultrasonography in the SFP

  9. Right paraspinal muscle (RPM) measurements in the SFP

    Time frame: 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 diameter measurement of the RPM in millimeters via ultrasonography in the SFP

  10. The mean of bilateral paraspinal muscles (MPM) in the SFP

    Time frame: 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.

    Measured by ( [LPM+RPM]/2) in millimeters in the SFP

  11. Subcutaneous tissue (ST) measurements in the SFP

    Time frame: 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 thickness measurement of the subcutaneous tissue in millimeters via ultrasonography in the SFP

  12. The skin to spinous process (S-SP) measurements in the SFP

    Time frame: 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 depth measurement of the skin to spinous process in millimeters via ultrasonography in the SFP

  13. the change of ISGO (ISGO ASP-SFP)

    Time frame: 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.

    Measured by calculation; ([ISGO in the ASP in millimeters]-[ISGO in the SFP in millimeters])

  14. the change of LPM (LPM ASP-SFP)

    Time frame: 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.

    Measured by calculation; ([LPM in ASP in millimeters]-[LPM in SFP in millimeters])

  15. the change of RPM (RPM ASP-SFP)

    Time frame: 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.

    Measured by calculation ([RPM in ASP in millimeters]-[RPM in SFP in millimeters])

  16. the change of MPM (MPM ASP-SFP)

    Time frame: 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.

    Measured by calculation ([MPM in ASP in millimeters]-[MPM in SFP in millimeters])

  17. the change of ST (ST ASP-SFP)

    Time frame: 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.

    Measured by calculation ([ST in ASP in millimeters]-[ST in SFP in millimeters])

  18. the change of S-SP (S-SP ASP-SFP)

    Time frame: 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.

    Measured by calculation ([S-SP in ASP in millimeters]-[S-SP in SFP in millimeters])

Secondary outcomes

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

    Time frame: 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 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.

  2. Comfort evaluation in the SFP via 5-point numerical rating scale (NRS)

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

Yeditepe University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 15, 2018
Registry last updated
Nov 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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