- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06761222
Impact of Ultrasound in Obstetric Anesthesia Central Blocks
The Impact of Ultrasound Use in Central Block Applications in Obstetric Anesthesia
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
İzmir, Turkey
- Şükran Özbebek
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Ultrasonography was conducted using a convex probe in the paramedian and transverse planes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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Preoperative
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Şükran ÖZBEBEK, MD, Ege Univesity
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 22-6.2/4
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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