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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
50
The anatomical evaluation of the two neuraxial positioning techniques sonographically and comparison of comfort with the 7-point NRS
Yeditepe University Hospital
Istanbul, İçerenköy, Turkey (Türkiye)
Interspinous gap opening (ISGO) measurement in the SCF
the wideness measurement of the ISGO in millimeters via ultrasonography (USG) 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.
Left paraspinal muscle (LPM) measurements in the SCF
the diameter measurement of the LPM in millimeters via ultrasonography 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.
Right paraspinal muscle (RPM) measurements in the SCF
the diameter measurement of the RPM in millimeters via ultrasonography 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 mean of bilateral paraspinal muscles (MPM) in the SCF
Measured by ( \[LPM+RPM\]/2) in millimeters 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.
Subcutaneous tissue (ST) measurements in the SCF
the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography 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 skin to spinous process (S-SP) measurements in the SCF
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the depth measurement of the skin to spinous process in millimeters via ultrasonography 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.
Interspinous gap opening (ISGO) measurement in the LDF
the wideness measurement of the ISGO in millimeters via ultrasonography 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.
Left paraspinal muscle (LPM) measurements in the LDF
the diameter measurement of the LPM in millimeters via ultrasonography 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.
Right paraspinal muscle (RPM) measurements in the LDF
the diameter measurement of the RPM in millimeters via ultrasonography 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 mean of bilateral paraspinal muscles (MPM) in the LDF
Measured by ( \[LPM+RPM\]/2) in millimeters 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.
Subcutaneous tissue (ST) measurements in the LDF
the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography 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 skin to spinous process (S-SP) measurements in the LDF
the depth measurement of the skin to spinous process in millimeters via ultrasonography 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 change of ISGO (ISGO SCF-LDF)
Measured by calculation; (\[ISGO in the SCF in millimeters\]-\[ISGO in the LDF in millimeters\])
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.
the change of LPM (LPM SCF-LDF )
Measured by calculation; (\[LPM in SCF in millimeters\]-\[LPM in LDF in millimeters\])
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.
the change of RPM (RPM SCF-LDF)
Measured by calculation (\[RPM in SCF in millimeters\]-\[RPM in LDF in millimeters\])
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.
the change of MPM (MPM SCF-LDF)
Measured by calculation (\[MPM in SCFin millimeters\]-\[MPM in LDF in millimeters\])
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.
the change of ST (ST SCF-LDF)
Measured by calculation (\[ST in SCF in millimeters\]-\[ST in LDF in millimeters\])
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.
the change of S-SP (S-SP SCF-LDF)
Measured by calculation (\[S-SP in SCF in millimeters\]-\[S-SP in LDF in millimeters\])
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.
Comfort evaluation in the SCF via 7-point numerical rating scale (NRS)
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.
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 in the LDF via 7-point numerical rating scale (NRS)
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.
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.