- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05642234
Comparison of Skin - Epidural and Intervertebral Distances in Sitting and Rider Position
Comparison of Skin - Epidural and Intervertebral Distances Measured by Ultrasonography in Sitting and Rider Position
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Nazim Ufuk Turhaner, MD
- Phone Number: 00905348284278
- Email: u.turhaner@gmail.com
Study Locations
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Fatih
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Istanbul, Fatih, Turkey, 34098
- Recruiting
- Istanbul University-Cerrahpasa
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Contact:
- Istanbul University-Cerrahpasa
- Phone Number: 69000 +902124143000
- Email: ctf@iuc.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
• ASA (American Society of Anesthesiologists) classification I-III
Exclusion Criteria:
- Prior spinal surgery
- Spinal deformity
- Recent spinal and head trauma
- Infection in the area to be measured
- Severe hypovolemia
- Severe edema
- severe abdominal distention
- Severe pain
- Difficulty in cooperation
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 minutes
|
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.
|
5 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Safak Emre Erbabacan, MD, Istanbul University-Cerrahpasa
- Study Director: Fatis Altındas, Prof., Istanbul University-Cerrahpasa
- Study Director: Cigdem Akyol Beyoglu, Assoc. Prof., Istanbul University-Cerrahpasa
- Study Director: Aylin Nizamoglu, Assoc. Prof., Istanbul University-Cerrahpasa
Publications and helpful links
General 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. 2021 Apr 19:S0104-0014(21)00140-8. doi: 10.1016/j.bjane.2021.03.010. Online ahead of print.
- Sahin 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.
- Sahin 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.
- Khemka 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.
- Soltani 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.
- Soltani 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 367794
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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