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

Anesthesia, Conduction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03741465
• Other study ID #: YeditepeU
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: September 20, 2018

Study information

• Verified date: November 2018
• Source: Yeditepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 (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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 20, 2018
• Est. primary completion date: September 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Conduction

Intervention

Procedure:
• The SFP technique
The USG, and the 5-point NRS evaluation in the SFP
• The ASP technique
The USG, and the 5-point NRS evaluation in the ASP

Locations

Country	Name	City	State
Turkey	Yeditepe University hospital	Istanbul	Içerenköy

Sponsors (1)

Lead Sponsor	Collaborator
Yeditepe University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Comfort evaluation in the ASP via 5-point numerical rating scale (NRS)	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.	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.
Secondary	Comfort evaluation in the SFP via 5-point numerical rating scale (NRS)	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.	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.