NCT06761222

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
Last Updated

January 7, 2025

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

December 19, 2024

Last Update Submit

December 30, 2024

Conditions

Keywords

Regional AnesthesiaCentral BlockObstetricsUltrasound

Outcome Measures

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

    Preoperative

Study Arms (1)

obstetric patient

EXPERIMENTAL

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

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

obstetric patient

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şükran Özbebek

Izmir, Turkey (Türkiye)

Location

Study Officials

  • Şükran ÖZBEBEK, MD

    Ege Univesity

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

December 19, 2024

First Posted

January 7, 2025

Study Start

June 15, 2022

Primary Completion

September 20, 2022

Study Completion

May 20, 2023

Last Updated

January 7, 2025

Record last verified: 2024-12

Locations