Clinical trial NCT06761222: Impact of Ultrasound in Obstetric Anesthesia Central Blocks
Official title: The Impact of Ultrasound Use in Central Block Applications in Obstetric Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: Regional Anesthesia
Central Block
Obstetrics
Ultrasound
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Investigating The Skin-to-subdural/epidural Distance and Needle Depth in Central Block applications
timeFrame: Preoperative
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Şükran Özbebek
Study officials:
affiliation: Ege Univesity
name: Şükran ÖZBEBEK, MD
role: STUDY_DIRECTOR
References: