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

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia Awareness
• Intervention / Treatment: Device: ultrasound

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey
    • Dokuz Eylul University
  • Narlidere
    • İzmir, Narlidere, Turkey, 35150
      • Dokuz Eylul Unicersity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: volunteer person; meausered by ultrasound	Device: ultrasound; measured by ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	six months

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Investigators: Study Chair: Semih Küçükgüçlü, doctor, Dokuz Eylul University

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Intraoperative Awareness
• Other Study ID Numbers: 2021/08/42

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No