Anesthesia, EpiduralNCT05642234
Comparison of Skin - Epidural and Intervertebral Distances in Sitting and Rider Position
An observational study of Anesthesia, Epidural and Analgesia, Epidural, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Epidural anesthesia/analgesia can be performed under various positions. In this study, the investigators aimed to compare the intervertebral and skin-epidural distances in "the sitting" and "rider" positions with the help of ultrasonography Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Epidural, Analgesia, Epidural, Ultrasound Imaging
- What is being tested?
- Epidural Ultrasonography
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 30 Mar 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study is carried out in patients over 18 years of age who will undergo abdominal surgery, with ASA (American Society of Anesthesiologists) classification I-III.
Who may be able to join
- ASA (American Society of Anesthesiologists) classification I-III
Who cannot join
- Prior spinal surgery
- Spinal deformity
- Recent spinal and head trauma
- Infection in the area to be measured
- Severe hypovolemia
- Severe edema
Show all 9Show fewer
- severe abdominal distention
- Severe pain
- Difficulty in cooperation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, Fatih, 34098
About this study
Official title: Comparison of Skin - Epidural and Intervertebral Distances Measured by Ultrasonography in Sitting and Rider Position
Epidural anesthesia/analgesia can be performed under various positions. In this study, the investigators aimed to compare the intervertebral and skin-epidural distances in "the sitting" and "rider" positions with the help of ultrasonography
Read the detailed description
Complication rates in epidural intervention, which can be used for both intraoperative and postoperative analgesia are higher than peripheral blocks, especially in open abdominal surgeries. In epidural intervention, correct determination of patient position, puncture site and the distance from the skin to the epidural area (skin - epidural distance) is very important in terms of preventing complications. The location of the point where the epidural intervention will be made is aimed to be determined using the anatomical surface markings in the blind technique. However, anatomical surface markings are unreliable in pregnant or obese patients and patients with anatomical variants. The use of pre-procedure ultrasonography allows obtaining information such as midline and baseline determination, skin-epidural distance measurement, increasing the success of the intervention.
The most preferred positions for epidural interventions are sitting and lateral decubitus positions. Many modifications of these positions also exist. The rider position is used in a few centers in and out of Turkey, but there is only one clinical study related to the position.
- Being tested
- Epidural Ultrasonography
- Keywords
- Epidural anesthesia, Rider position, İntervertebral distance, Skin-epidural distance
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural UltrasonographyProcedure or surgery
In this study, we measured the intervertebral distance and skin-epidural distance with the help of ultrasonography in the thoracic and lumbar regions in sitting and rider positions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervertebral distance
Comparison of intervertebral distance measurements with the help of ultrasonography in the thoracic and lumbar regions in sitting and rider positions.
Measured: 5 minutes
Skin - epidural distance
Comparison of skin - epidural distance measurements with the help of ultrasonography in the thoracic and lumbar regions in sitting and rider positions.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Sep 2022
- Primary completion1 Jan 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, EpiduralStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazim Ufuk Turhaner, Istanbul University - Cerrahpasa
- Investigators
- Safak Emre Erbabacan, MD, Study chair, Istanbul University - CerrahpasaFatis Altındas, Prof., Study director, Istanbul University - CerrahpasaCigdem Akyol Beyoglu, Assoc. Prof., Study director, Istanbul University - CerrahpasaAylin Nizamoglu, Assoc. Prof., Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642234
- Sponsor's protocol ID
- 367794
- Status last verified
- Sep 2024
- First submitted
- 28 Nov 2022
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share information about gender, age, height, body weight, ASA class, diagnosis, surgery, thoracic and lumbar intervertebral and skin-epidural distances measured in the rider and sitting positions
Publications
Korkmaz Toker M, Altiparmak B, Uysal AI, Turan M, Gumus Demirbilek S. Rider sitting position widens lumbar intervertebral distance: a prospective observational study. Braz J Anesthesiol. 2023 Nov-Dec;73(6):758-763. doi: 10.1016/j.bjane.2021.03.010. Epub 2021 Apr 19.
PubMed 33887338Sahin T, Balaban O, Sahin L, Solak M, Toker K. A randomized controlled trial of preinsertion ultrasound guidance for spinal anaesthesia in pregnancy: outcomes among obese and lean parturients: ultrasound for spinal anesthesia in pregnancy. J Anesth. 2014 Jun;28(3):413-9. doi: 10.1007/s00540-013-1726-1. Epub 2013 Oct 20.
PubMed 24141882Sahin T, Balaban O. Lumbar Ultrasonography for Obstetric Neuraxial Blocks: Sonoanatomy and Literature Review. Turk J Anaesthesiol Reanim. 2018 Aug;46(4):257-267. doi: 10.5152/TJAR.2018.90277. Epub 2018 Aug 1.
PubMed 30140531Khemka R, Rastogi S, Desai N, Chakraborty A, Sinha S. Comparison of ultrasound imaging in transverse median and parasagittal oblique planes for thoracic epidurals: A pilot study. Indian J Anaesth. 2016 Jun;60(6):377-81. doi: 10.4103/0019-5049.183398.
PubMed 27330197Soltani Mohammadi S, Piri M, Khajehnasiri A. Comparing Three Different Modified Sitting Positions for Ease of Spinal Needle Insertion in Patients Undergoing Spinal Anesthesia. Anesth Pain Med. 2017 Oct 23;7(5):e55932. doi: 10.5812/aapm.55932. eCollection 2017 Oct.
PubMed 29696117Soltani Mohammadi S, Hassani M, Marashi SM. Comparing the squatting position and traditional sitting position for ease of spinal needle placement: a randomized clinical trial. Anesth Pain Med. 2014 Apr 5;4(2):e13969. doi: 10.5812/aapm.13969. eCollection 2014 May.
PubMed 24790901
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Skin - Epidural and Intervertebral Distances Measured by Ultrasonography in Sitting and Rider Position
- ClinicalTrials.gov ID
- NCT05642234
- Acronym / sponsor ID
- 367794
- Keywords
- Epidural anesthesia, Rider position, İntervertebral distance, Skin-epidural distance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 8 Dec 2022 (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.
Epidural anesthesia/analgesia can be performed under various positions. In this study, the investigators aimed to compare the intervertebral and skin-epidural distances in "the sitting" and "rider" positions with the help of ultrasonography
Detailed description
Complication rates in epidural intervention, which can be used for both intraoperative and postoperative analgesia are higher than peripheral blocks, especially in open abdominal surgeries. In epidural intervention, correct determination of patient position, puncture site and the distance from the skin to the epidural area (skin - epidural distance) is very important in terms of preventing complications. The location of the point where the epidural intervention will be made is aimed to be determined using the anatomical surface markings in the blind technique. However, anatomical surface markings are unreliable in pregnant or obese patients and patients with anatomical variants. The use of pre-procedure ultrasonography allows obtaining information such as midline and baseline determination, skin-epidural distance measurement, increasing the success of the intervention.
The most preferred positions for epidural interventions are sitting and lateral decubitus positions. Many modifications of these positions also exist. The rider position is used in a few centers in and out of Turkey, but there is only one clinical study related to the position.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study is carried out in patients over 18 years of age who will undergo abdominal surgery, with ASA (American Society of Anesthesiologists) classification I-III.
Key inclusion criteria (1 listed)
- ASA (American Society of Anesthesiologists) classification I-III
Key exclusion criteria (9 listed)
- Prior spinal surgery
- Spinal deformity
- Recent spinal and head trauma
- Infection in the area to be measured
- Severe hypovolemia
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 |
|---|---|---|
| Epidural UltrasonographyIn this study, we measured the intervertebral distance and skin-epidural distance with the help of ultrasonography in the thoracic and lumbar regions in sitting and rider positions. | Procedure or surgery | – |
Primary outcome
Intervertebral distance
Time frame: 5 minutes
Comparison of intervertebral distance measurements with the help of ultrasonography in the thoracic and lumbar regions in sitting and rider positions.
Skin - epidural distance
Time frame: 5 minutes
Comparison of skin - epidural distance measurements with the help of ultrasonography in the thoracic and lumbar regions in sitting and rider positions.
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 20 Sep 2024.
- Background: PubMed 33887338Korkmaz Toker M, Altiparmak B, Uysal AI, Turan M, Gumus Demirbilek S. Rider sitting position widens lumbar intervertebral distance: a prospective observational study. Braz J Anesthesiol. 2023 Nov-Dec;73(6):758-763. doi: 10.1016/j.bjane.2021.03.010. Epub 2021 Apr 19.
- Background: PubMed 24141882Sahin T, Balaban O, Sahin L, Solak M, Toker K. A randomized controlled trial of preinsertion ultrasound guidance for spinal anaesthesia in pregnancy: outcomes among obese and lean parturients: ultrasound for spinal anesthesia in pregnancy. J Anesth. 2014 Jun;28(3):413-9. doi: 10.1007/s00540-013-1726-1. Epub 2013 Oct 20.
- Background: PubMed 30140531Sahin T, Balaban O. Lumbar Ultrasonography for Obstetric Neuraxial Blocks: Sonoanatomy and Literature Review. Turk J Anaesthesiol Reanim. 2018 Aug;46(4):257-267. doi: 10.5152/TJAR.2018.90277. Epub 2018 Aug 1.
- Background: PubMed 27330197Khemka R, Rastogi S, Desai N, Chakraborty A, Sinha S. Comparison of ultrasound imaging in transverse median and parasagittal oblique planes for thoracic epidurals: A pilot study. Indian J Anaesth. 2016 Jun;60(6):377-81. doi: 10.4103/0019-5049.183398.
- Background: PubMed 29696117Soltani Mohammadi S, Piri M, Khajehnasiri A. Comparing Three Different Modified Sitting Positions for Ease of Spinal Needle Insertion in Patients Undergoing Spinal Anesthesia. Anesth Pain Med. 2017 Oct 23;7(5):e55932. doi: 10.5812/aapm.55932. eCollection 2017 Oct.
- Background: PubMed 24790901Soltani Mohammadi S, Hassani M, Marashi SM. Comparing the squatting position and traditional sitting position for ease of spinal needle placement: a randomized clinical trial. Anesth Pain Med. 2014 Apr 5;4(2):e13969. doi: 10.5812/aapm.13969. eCollection 2014 May.
- Individual participant dataSharing planned: Yes. We will share information about gender, age, height, body weight, ASA class, diagnosis, surgery, thoracic and lumbar intervertebral and skin-epidural distances measured in the rider and sitting positions
Related trials for Anesthesia, Epidural
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
RecruitingPhase 2/3
Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
Postdural Puncture Headache (PDPH)
Recruiting
Comparison of Echo-assisted ALR Technique and Traditional ALR Technique for the Placement of an Epidural Catheter in the Obstetric Patient
Pregnancy
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery
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.
Safak Emre Erbabacan, MD study chair
Istanbul University - Cerrahpasa
Fatis Altındas, Prof. study director
Istanbul University - Cerrahpasa
Cigdem Akyol Beyoglu, Assoc. Prof. study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Epidural and Analgesia, Epidural, run by Istanbul University - Cerrahpasa 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 1 inclusion and 9 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 20 Sep 2024. 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?
Intervertebral distance (time frame: 5 minutes). The study lists 2 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 NCT05642234, which also lists 6 linked publications.
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 20 Sep 2024.