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Completed

NCT Number: NCT06316622

Examination of The Relationshıp Between Body Mass Index And The Skin-Epidural Space Distance

Aim: The aim of the study; to investigate whether there is a relationship between body mass index (BMI), waist circumference, and abdominal subcutaneous adipose tissue and the skin-epidural space distance measured by USG.

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Key information

Age range

21 year–58 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul Unicersity, Izmir, Narlidere, Turkey (Türkiye)

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About this study

The research was carried out in the block room in the preoperating room of Dokuz Eylül University Practice and Research Hospital and with 42 volunteer operating room workers aged between 18-59 years. Height, weight and waist circumference measurements were made with standard measuring instruments, and other measurements were completed by ultrasonography (USG) separately by an anesthesiologist and a radiologist. For ultrasonographic evaluation, left lateral decubitus, right lateral decubitus and in sitting position, skin-dural junction, skin-vertebra corpus, anterior complex distances, upper and lower SIAS levels were examined with convex probe as transverse median. In addition, abdominal subcutaneous fat thickness measurements were made with a linear probe in the supine position. The statistical correlations of all measurements were examined.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 59 years old.
  • ASA I-II classification.
  • Body Mass Index (BMI): 18.5-29.9 kg/m2.

Exclusion criteria

  • Individuals under 18 or over 59 years old.
  • Those with a history of vertebral surgery.
  • Patients diagnosed with spinal deformities (excluding scoliosis ≤10 degrees, kyphosis <30 or >80 degrees).
  • Individuals with rheumatologic diseases affecting skeletal structure such as ankylosing spondylitis, rheumatoid arthritis.
  • Presence of wounds or infections in the lumbar region.
  • Volunteers who underwent epidural or spinal interventions in the lumbar region within the last month.
  • Individuals with bone implants affecting posture, such as hip or knee prostheses.
  • Pregnant women.
  • Individuals with conditions like Cushing's syndrome, hypothyroidism, acromegaly causing lumbar edema.
  • Volunteers using corticosteroids.
  • Obese individuals (BMI: >29.9).

Treatment and study plan

Ultrasound

Device

measured by ultrasound

Primary outcomes

  1. We examined the relationships between body mass index calculated by measuring weight and height, subcutaneous fat tissue in the abdominal region and the skin-epidural space distance in the lumbar region; measured by ultrasound.

    Time frame: six months

    Unexpectedly low skin-epidural space distances can be seen even in individuals with high weight and fat content.

    For the targeted space between above the anterior superior iliac spine (ASIS) (estimated L3-L4) and below the ASIS, each patient was positioned in the left lateral, right lateral and then sitting positions, with a transverse-median approach performed by an anaesthetist followed by a radiologist. Skin-dural composite (SDC), skin-vertebral body and anterior complex (posterior longitudinal ligament) distance measurements were recorded separately. Subcutaneous abdominal fat thickness was measured using a linear probe of an ultrasound device (LOGIQ-E, GE Medical Systems, China) to ensure consistency. Measurements were taken at two points (right lateral, left lateral) 2 cm away from the umbilicus and recorded by averaging. Waist circumference was measured using a standard measuring tape at the navel level in all volunteers.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

Examination of the Relationship Between Body Mass Index and the Skin-epidural Space Distance Measured by Ultrasound in the Lumbar Region

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2024
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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