AnesthesiaNCT06761222
Impact of Ultrasound in Obstetric Anesthesia Central Blocks
A study testing The use of ultrasound in central blocks in people with Anesthesia, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Anesthesia
- What is being tested?
- The use of ultrasound in central blocks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2022to 20 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patients who did not consent to spinal anesthesia
- Patients with contraindications for regional anesthesia (coagulopathy, local or systemic infection)
- Emergency patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Ultrasound Use in Central Block Applications in Obstetric Anesthesia
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.
Read the 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
- Being tested
- The use of ultrasound in central blocks
- Keywords
- Regional Anesthesia, Central Block, Obstetrics, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The use of ultrasound in central blocksOther
Ultrasonography was conducted using a convex probe in the paramedian and transverse planes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: The use of ultrasound in central blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start15 Jun 2022
- Primary completion20 Sep 2022
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sukran Ozbebek, Ege University
- Investigators
- Şükran ÖZBEBEK, MD, Study director, Ege Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761222
- Sponsor's protocol ID
- 22-6.2/4
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ultrasound Use in Central Block Applications in Obstetric Anesthesia
- ClinicalTrials.gov ID
- NCT06761222
- Acronym / sponsor ID
- 22-6.2/4
- Conditions
- Anesthesia
- Keywords
- Regional Anesthesia, Central Block, Obstetrics, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obstetric patient | Experimental | Other: The use of ultrasound in central blocksRegional 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Patients who did not consent to spinal anesthesia
- Patients with contraindications for regional anesthesia (coagulopathy, local or systemic infection)
- Emergency patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The use of ultrasound in central blocksUltrasonography was conducted using a convex probe in the paramedian and transverse planes. | Other | obstetric patient |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şükran ÖZBEBEK, MD study director
Ege Univesity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The use of ultrasound in central blocks in people with Anesthesia, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigating The Skin-to-subdural/epidural Distance and Needle Depth in Central Block applications (time frame: Preoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.