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Completed

NCT Number: NCT03889223

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

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.

Completed

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Key information

Conditions

Anesthesia, Conduction

Age range

18 year–65 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 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).

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Anatomical intervention with USG and comfort evaluation with NRS

Procedure

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

Primary outcomes

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

    Time frame: For the SCF technique, ISGO is measured in the first 10 minutes(mins.) time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

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

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

    Time frame: For the SCF technique, LPM is measured between the 10th and 20th mins. of the study, in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

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

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

    Time frame: For the SCF technique, RPM is measured in between the 20th and 30th mins. of the study, in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

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

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

    Time frame: For the SCF technique, MPM measurement is planned to be done in between the 30th and 40th mins. of the study,in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

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

  5. Subcutaneous tissue (ST) measurements in the SCF

    Time frame: For the SCF technique, ST measurement is planned to be done in between the 40th and 50th mins. of the study,in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

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

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

    Time frame: : For the SCF technique, S-SP measurement is planned to be done in between the 50th and 60th mins. of the study,in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

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

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

    Time frame: ISGO measurement in the LDF will be done right after NRS evaluation of the SCF, in between the 70th and 80th mins. of the study,in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

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

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

    Time frame: LPM measurement in the LDF will be done in between the 80th and 90th mins. of the study,in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

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

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

    Time frame: RPM measurement in the LDF will done in between the 90th and 100th mins. of the study, in 10 mins. time of the total 3hr and 30 mins. study, for each participant through study completion up to 20 weeks.

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

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

    Time frame: MPM measurement in the LDF will be done in between the 100th and 110th mins. time of the study, in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

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

  11. Subcutaneous tissue (ST) measurements in the LDF

    Time frame: ST measurement in the LDF will be done in between the 110th and 120th mins. time, in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

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

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

    Time frame: S-SP measurement in the LDF will be done in between the 120th and 130th mins. of the study, in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

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

  13. the change of ISGO (ISGO SCF-LDF)

    Time frame: ISGO in the SCF measured in the first 10mins., and ISGO in the LDF measured in between the 70th and 80th mins. of the study, in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

    Measured by calculation; ([ISGO in the SCF in millimeters]-[ISGO in the LDF in millimeters])

  14. the change of LPM (LPM SCF-LDF )

    Time frame: LPM in the SCF measured in between the 10th and 20th mins., and LPM in the LDF measured in between the 80th and 90th mins., in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

    Measured by calculation; ([LPM in SCF in millimeters]-[LPM in LDF in millimeters])

  15. the change of RPM (RPM SCF-LDF)

    Time frame: RPM in the SCF measured in between the 20th and 30th mins., and RPM in the LDF measured in between 90th and 100th mins., in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

    Measured by calculation ([RPM in SCF in millimeters]-[RPM in LDF in millimeters])

  16. the change of MPM (MPM SCF-LDF)

    Time frame: MPM in the SCF measured in between the 30th and 40th mins., and MPM in the LDF measured in between 100th and 110th mins., in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

    Measured by calculation ([MPM in SCFin millimeters]-[MPM in LDF in millimeters])

  17. the change of ST (ST SCF-LDF)

    Time frame: ST in the SCF measured in between the 40th and 50th mins., and ST in the LDF measured in between the 110th and 120th, in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

    Measured by calculation ([ST in SCF in millimeters]-[ST in LDF in millimeters])

  18. the change of S-SP (S-SP SCF-LDF)

    Time frame: S-SP in the SCF measured in between the 50th and 60th mins., and S-SP in the LDF measured in between the 120th and 130th mins., in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

    Measured by calculation ([S-SP in SCF in millimeters]-[S-SP in LDF in millimeters])

Secondary outcomes

  1. Comfort evaluation in the SCF via 7-point numerical rating scale (NRS)

    Time frame: NRS measurement is planned to be done right after the SCF position in between the 60th and 70th mins. time,in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks..

    Comfort evaluation of the SCF technique is planned to be done by the participant right after USG. The 7-point NRS includes 7 scale. The minimum scale is"1" means very bad, "2" means bad, "3" means fair, "4" means normal, "5" means good, "6" means very good, and the maximum scale is "7" means excellent.

  2. Comfort evaluation in the LDF via 7-point numerical rating scale (NRS)

    Time frame: NRS measurement is planned to be done right after the LDF position in between the 130th and 140th mins. time of the study, in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

    Comfort evaluation of the LDF technique is planned to be done by the participant right after USG. The 7-point NRS includes 7 scale. The minimum scale is"1" means very bad, "2" means bad, "3" means fair, "4" means normal, "5" means good, "6" means very good, and the maximum scale is "7" means excellent.

Sponsors and collaborators

Lead sponsor

Yeditepe University

Other

Registry information

Official study title

Ultrasonographic and Comfort Comparison of Sitting Fetal Cross-legged Position With Lateral Decubitus Fetal Position on Healthy Volunteers; a Randomized, Consecutive-controlled Clinical Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 26, 2019
Registry last updated
Jul 1, 2019

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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