Clinical trial NCT05642234: Comparison of Skin - Epidural and Intervertebral Distances in Sitting and Rider Position
Official title: Comparison of Skin - Epidural and Intervertebral Distances Measured by Ultrasonography in Sitting and Rider Position
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Epidural
Analgesia, Epidural
Ultrasound Imaging
Keywords: Epidural anesthesia
Rider position
İntervertebral distance
Skin-epidural distance
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intervertebral distance
timeFrame: 5 minutes
measure: Skin - epidural distance
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Fatih
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Safak Emre Erbabacan, MD
role: STUDY_CHAIR
affiliation: Istanbul University - Cerrahpasa
name: Fatis Altındas, Prof.
role: STUDY_DIRECTOR
affiliation: Istanbul University - Cerrahpasa
name: Cigdem Akyol Beyoglu, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Istanbul University - Cerrahpasa
name: Aylin Nizamoglu, Assoc. Prof.
role: STUDY_DIRECTOR
References:
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. 2023 Nov-Dec;73(6):758-763. doi: 10.1016/j.bjane.2021.03.010. Epub 2021 Apr 19.
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.
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.
citation: 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.
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.
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.