CClinicalTrials.gg
CompletedNCT06761222Updated Jan 7, 2025

Impact of Ultrasound in Obstetric Anesthesia Central Blocks

An interventional study of The use of ultrasound in central blocks in Anesthesia, sponsored by Ege University. Completed at 1 site in Turkey. Open to female participants. Per ClinicalTrials.gov, last updated 2025-01-07.

Sponsored by Ege University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Jun 2022, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Sex
Female
01

Study summary

This study aimed to evaluate the use of ultrasound in obstetric anesthesia, specifically for measuring epidural and intrathecal distances in pregnant women undergoing cesarean section. The relationship between skin-subdural distance (Ultrasound depth) and needle depth was assessed, and the accuracy of ultrasound in determining needle entry site, needle distance, trial attempts, and block success was examined. Additionally, complications such as paresthesia, lower back pain, and postoperative headache were queried and recorded.

Read the detailed description

Obstetric anesthesia generally posed low risks; however, the difficulty of the procedure and the potential complications increased due to the anatomical and physiological changes associated with pregnancy.

The aim of study was to measure epidural and intrathecal distances in pregnant women undergoing cesarean sections and to evaluate the relationship between the skin-subdural distance (Ultrasound depth) and needle depth. The investigator assessed the accuracy of Ultrasound in determining the needle entry site, needle distance (measured at the site where cerebrospinal fluid flow occurred or where there was a loss of resistance in the epidural space), trial numbers, and block success. Additionally, occurrences of paresthesia and lower back pain during the procedure, as well as postoperative headaches following dural puncture, were queried and recorded.

After obtaining approval from the Ege University Faculty of Medicine Ethical Committee, the study was prospectively conducted in the operating room of the Department of Obstetrics and Gynecology at Ege University Hospital. One hundred pregnant women classified as ASA I-II, between 37-42 gestational weeks, undergoing elective cesarean sections with neuraxial blocks (spinal and/or epidural), were included after obtaining their consent.

02

Conditions studied

  • Anesthesia

Keywords

  • Regional Anesthesia
  • Central Block
  • Obstetrics
  • Ultrasound
03

In context

Lead sponsor

Ege University is the lead sponsor of 365 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Patients classified as ASA I-II
  • Patients at 37-42 gestational weeks
  • Patients scheduled for elective cesarean section under neuraxial block (spinal and/or epidural)

Exclusion criteria

Exclusion Criteria:

  • Patients who did not consent to spinal anesthesia
  • Patients with contraindications for regional anesthesia (coagulopathy, local or systemic infection)
  • Emergency patients
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    obstetric patient

    Regional block procedures were performed on all patients included in the study in a sitting position, using the most appropriate interspinous space among L3-L4-L5-S1. Ultrasonography was conducted using a convex probe in the paramedian and transverse planes, and the images were recorded. Regional (spinal and/or epidural) anesthesia was provided by entering the lumbar space identified with ultrasonography.

    Other: The use of ultrasound in central blocks

Interventions

  • OtherThe use of ultrasound in central blocks

    Ultrasonography was conducted using a convex probe in the paramedian and transverse planes.

06

What researchers measure

Primary outcomes

  1. Investigating The Skin-to-subdural/epidural Distance and Needle Depth in Central Block applications

    The Use of Ultrasonography in Central Block Applications in Obstetric Patients

    Time frame: Preoperative

07

Study locations

1 site
  • Şükran Özbebek
    İzmir, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06761222
Lead sponsor
Ege University
Responsible party
Sukran Ozbebek (Anesthesiologist, Ege University) — Principal investigator
First posted
Jan 7, 2025
Start date
Jun 15, 2022
Primary completion
Sep 20, 2022
Completion
May 20, 2023
Last update
Jan 7, 2025

Study contacts

Şükran ÖZBEBEK, MD
study director · Ege Univesity

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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