Anesthesia, ConductionNCT03889223

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

A study testing Anatomical intervention with USG and comfort evaluation with NRS in people with Anesthesia, Conduction, run by Yeditepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Anesthesia, Conduction
What is being tested?: Anatomical intervention with USG and comfort evaluation with NRS
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 20 Mar 2019to 25 Jun 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Yeditepe University Hospital
Istanbul, İçerenköy

Other trials in Turkey (Türkiye)

About this study

Official 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

Secondary aim is to compare their comfort.

Read the 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).

Conditions: Anesthesia, Conduction
Being tested: Anatomical intervention with USG and comfort evaluation with NRS
Keywords: neuraxial anesthesia positioning technique, sitting cross-legged fetal position, lateral decubitus fetal position, ultrasonography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anatomical intervention with USG and comfort evaluation with NRSProcedure or surgery
The anatomical evaluation of the two neuraxial positioning techniques sonographically and comparison of comfort with the 7-point NRS

Study groups in NCT03889223
Study group	Role	What they receive
The LDF neuraxial positioning technique	Active comparator	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. Receives: Procedure: Anatomical intervention with USG and comfort evaluation with NRS
The SCF neuraxial positioning technique	Experimental	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. Receives: Procedure: Anatomical intervention with USG and comfort evaluation with NRS

What is being measured

The primary outcome is the main question the study is designed to answer.

Interspinous gap opening (ISGO) measurement in the SCF
the wideness measurement of the ISGO in millimeters via ultrasonography (USG) in the SCF
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
the depth measurement of the skin to spinous process in millimeters via ultrasonography in the SCF
Measured: : 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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])
Measured: 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])
Measured: 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])
Measured: 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])
Measured: 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])
Measured: 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])
Measured: 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.

Secondary outcomes (2)

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.
Measured: 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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Mar 201925 Jun 2019

First posted26 Mar 2019
Study start20 Mar 2019
Primary completion15 Jun 2019
Study completion25 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Anesthesia, ConductionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
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 SCF and LDF. 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 7-point numerical rating scale from minimum 1 meaning "very bad" to maximum 7 meaning "excellent."
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03889223
Sponsor's protocol ID: KAEK- tez
Status last verified: Jun 2019
First submitted: 12 Mar 2019
Last updated: 1 Jul 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 27687365

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT03889223
Acronym / sponsor ID: KAEK- tez
Conditions: Anesthesia, Conduction
Keywords: neuraxial anesthesia positioning technique, sitting cross-legged fetal position, lateral decubitus fetal position, ultrasonography
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Yeditepe UniversityUniversity, hospital or other
Study start: 20 Mar 2019 (actual)
Primary completion: 15 Jun 2019 (actual)
Study completion: 25 Jun 2019 (actual)
First posted: 26 Mar 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Secondary aim is to compare their comfort.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind (outcomes assessor)
Number of arms: 2
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 SCF and LDF. 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 7-point numerical rating scale from minimum 1 meaning "very bad" to maximum 7 meaning "excellent."

Arm	Type	Receives
The LDF neuraxial positioning technique	Active comparator	Procedure: Anatomical intervention with USG and comfort evaluation with NRSIn 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.
The SCF neuraxial positioning technique	Experimental	Procedure: Anatomical intervention with USG and comfort evaluation with NRSIn 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (7 listed)

Lumbar hernia,
Scoliosis,
History of spine surgery,
History of trauma,
History of lower back pain,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Anatomical intervention with USG and comfort evaluation with NRSThe anatomical evaluation of the two neuraxial positioning techniques sonographically and comparison of comfort with the 7-point NRS	Procedure or surgery	The LDF neuraxial positioning technique, The SCF neuraxial positioning technique

Primary outcome

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])

2 secondary outcomes

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 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
Results publication: PubMed 27687365Dimaculangan 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Anatomical intervention with USG and comfort evaluation with NRS in people with Anesthesia, Conduction, run by Yeditepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03889223, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2019.