Clinical trial NCT03741465: A New Neuraxial Position Technique " The Anatolian Sitting Position- Sitting Fetal Cross-legged"
Official title: "The Anatolian Sitting Neuraxial Position Technique"; is it Beneficial? A Prospective Clinical Comparison Trial Via Ultrasonography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Conduction
Keywords: neuraxial anesthesia positioning technique
Anatolian sitting position
sitting cross-legged position
sitting fetal position
ultrasonography
numerical rating scale
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Systematic randomization was made from 150 volunteers, and 50 participants were chosen.

All 50 participants were planned to sit on the stretcher in both of the two positioning techniques sequentially (one after another). The two positioning techniques are 1) sitting fetal position-" the SFP" ( a traditional position ) and 2) sitting fetal cross-legged-" the ASP" ( a new position, named as " Anatolian sitting position"). The investigator was planned to record all of the participants' anatomical measurements in both of those positioning techniques evaluated via ultrasonography. After each position participants were planned to evaluate each positioning technique's comfort by 5-point numerical rating scale from minimum 1 meaning "poor" to maximum 5 meaning "excellent."
Primary purpose: OTHER

Brief 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.

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 (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).

Eligibility criteria: 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.

Primary outcomes:
measure: Interspinous gap opening (ISGO) measurement in the ASP
timeFrame: For the ASP technique, ISGO is measured in the first 10 minutes(mins.) time, for each participant, through study completion.
measure: Left paraspinal muscle (LPM) measurements in the ASP
timeFrame: For the ASP technique, LPM is measured in between 10mins. and 20mins. time, for each participant, through study completion.
measure: Right paraspinal muscle (RPM) measurements in the ASP
timeFrame: For the ASP technique, RPM is measured in between 20mins. and 30mins. time, for each participant, through study completion.
measure: The mean of bilateral paraspinal muscles (MPM) in the ASP
timeFrame: For the ASP technique, MPM measurement is planned to be done in between 30mins. and 40mins. time, for each participant, through study completion.
measure: Subcutaneous tissue (ST) measurements in the ASP
timeFrame: For the ASP technique, ST measurement is planned to be done in between 40mins. and 50mins. time, for each participant, through study completion.
measure: The skin to spinous process (S-SP) measurements in the ASP
timeFrame: 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.
measure: Interspinous gap opening (ISGO) measurement in the SFP
timeFrame: 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.
measure: Left paraspinal muscle (LPM) measurements in the SFP
timeFrame: 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.
measure: Right paraspinal muscle (RPM) measurements in the SFP
timeFrame: 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.
measure: The mean of bilateral paraspinal muscles (MPM) in the SFP
timeFrame: 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.
measure: Subcutaneous tissue (ST) measurements in the SFP
timeFrame: For the SFP technique, ST measurement is planned to be done in between 1hr.50mins. and 2hrs. time, for each participant, through study completion.
measure: The skin to spinous process (S-SP) measurements in the SFP
timeFrame: 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.
measure: the change of ISGO (ISGO ASP-SFP)
timeFrame: 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.
measure: the change of LPM (LPM ASP-SFP)
timeFrame: 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.
measure: the change of RPM (RPM ASP-SFP)
timeFrame: 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.
measure: the change of MPM (MPM ASP-SFP)
timeFrame: 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.
measure: the change of ST (ST ASP-SFP)
timeFrame: 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.
measure: the change of S-SP (S-SP ASP-SFP)
timeFrame: 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 outcomes:
measure: Comfort evaluation in the ASP via 5-point numerical rating scale (NRS)
timeFrame: 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.
measure: Comfort evaluation in the SFP via 5-point numerical rating scale (NRS)
timeFrame: 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.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University hospital
state: İçerenköy
Study officials:
name: ferda kartufan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.