Impact of Ultrasound in Obstetric Anesthesia Central Blocks

NCT ID: NCT06761222

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2023-05-20

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.

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.

Conditions

Anesthesia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

The use of ultrasound in central blocks

Intervention Type: OTHER

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

Interventions

The use of ultrasound in central blocks

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

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Sukran Ozbebek

Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Şükran ÖZBEBEK, MD

Role: STUDY_DIRECTOR

Ege Univesity

Locations

Şükran Özbebek

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

22-6.2/4

Identifier Type: -

Identifier Source: org_study_id