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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Other
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 15, 2019

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 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).

Interventions

  • Procedure: Anatomical intervention with USG and comfort evaluation with NRS
    • The anatomical evaluation of the two neuraxial positioning techniques sonographically and comparison of comfort with the 7-point NRS

Arms, Groups and Cohorts

  • Active Comparator: The LDF neuraxial positioning technique
    • In the LDF neuraxial positioning technique, fifty participants were planned to lay down the stretcher facing the wall of the sonography room and turned back to the consultant Radiologist. Volunteers jaw touch to chest and legs in abdominal flexion with hands 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 7-point NRS evaluation is done by each participant in maximum 30 minutes time until the study ends within 15 weeks.
  • Experimental: The SCF neuraxial positioning technique
    • In the SCF 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 7-point NRS evaluation is done by each participant in maximum 30 minutes time until the study ends within 15 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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])
  • 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])
  • 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])
  • 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])
  • 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])
  • 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 Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Yeditepe University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Fatma Ferda Kartufan, Assistant Professor – Yeditepe University
  • Overall Official(s)
    • Ferda Kartufan, Assist.Prof., Principal Investigator, Anesthesiology and Reanimation Department
    • Feyza Aksu, MD, Study Chair, Anesthesiology and Reanimation Department
    • Özge Köner, Prof., Study Director, Anesthesiology and Reanimation Department
    • Ayşegül Görmez, Consult.MD, Study Chair, Radiology Department

Citations Reporting on Results

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.

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