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OpenTrials
Completed

NCT Number: NCT06761222

Impact of Ultrasound in Obstetric Anesthesia Central Blocks

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.

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Key information

Conditions

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Şükran Özbebek

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

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

Treatment and study plan

The use of ultrasound in central blocks

Other

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

Primary outcomes

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

    Time frame: Preoperative

    The Use of Ultrasonography in Central Block Applications in Obstetric Patients

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

The Impact of Ultrasound Use in Central Block Applications in Obstetric Anesthesia

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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