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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05642234
Other study ID # 367794
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date January 1, 2023

Study information

Verified date December 2022
Source Istanbul University - Cerrahpasa (IUC)
Contact Nazim Ufuk Turhaner, MD
Phone 00905348284278
Email u.turhaner@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date January 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
Epidural Ultrasonography
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.

Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul Fatih

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Intervertebral distance Comparison of intervertebral distance measurements with the help of ultrasonography in the thoracic and lumbar regions in sitting and rider positions. 5 minutes
Primary 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. 5 minutes
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