Anesthesia, CaudalNCT03825172
Evaluation Of Caudal Epidural Anatomy By Ultrasonography İn Pediatric Patients
An observational study of Anesthesia, Caudal and Anatomy, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Detailed study of ultrasonographic caudal epidural anatomy Read more about this study
- Who is it for?
- Ages 1 month to 84 months
- Conditions the study is for
- Anesthesia, Caudal, Anatomy, Ultrasonography
- What is being tested?
- Caudal Epidural Ultrasonography
- How many people
- 348 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jan 2019to 20 Jan 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 1 month to 84 months
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients who are admitted to operating room for any pediatric surgery
Who may be able to join
- Pediatric patients who applied for any pediatric surgery from 20 january to 20 july
Who cannot join
- Premature patients
- Patients who have any sendromic diagnosis
- Patients who have any musculoskeletal abnormalities
- Patients who have any spinal abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Detailed study of ultrasonographic caudal epidural anatomy
Read the detailed description
Caudal epidural block is one of the most common methods to provide analgesia for an infraumbilical surgery in children. Although it can be carried out safely and easily, many complications have been described so far, because of inaccurate needle injections. To perform a successful block, a good caudal epidural anatomic assessment is essential. Ultrasonography is an important tool to perform pediatric regional blocks, including caudal blocks. We believe that caudal epidural ultrasound evaluation can be an important option to decrease complications and to achieve a successful attempt; due to that we will try to describe caudal epidural ultrasound imaging and changes from one month to 84 months.
- Conditions
- Anesthesia, Caudal, Anatomy, Ultrasonography, Pediatrics
- Being tested
- Caudal Epidural Ultrasonography
- Keywords
- Caudal block, Ultrasound, Children, Regional block anatomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal Epidural UltrasonographyDiagnostic test
Ultrasonographic Measurement
| Study group | Role | What they receive |
|---|---|---|
| Group I | Caudal Epidural Ultrasonography will be performed in patients aged between 1-24 months Receives: Diagnostic Test: Caudal Epidural Ultrasonography | |
| Group II | Caudal Epidural Ultrasonography will be performed in patients aged between 25-48 months Receives: Diagnostic Test: Caudal Epidural Ultrasonography | |
| Group III | Caudal Epidural Ultrasonography will be performed in patients aged between 49-84 months Receives: Diagnostic Test: Caudal Epidural Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Definition Of Dural Sac Termination Level By Ultrasonography
After general anesthesia, patient will be placed in lateral decubitus position. First, a 12 MHz lineer ultrasound transducer will be placed transversely to obtain the transverse view of sacral hiatus; in this view we will try to show two sacral cornua, sacrococcygeal ligament, posterior sacral bone and caudal epidural depth. Secondly, transducer will be turned parallel to the midline or paravertebral to obtain longitudinal view; in longitudinal view we will try to obtain the images of sacral vertebral corpuses, caudal epidural area and dural sac. We will try to determine the level of dural sac termination according to a part of vertabral corpus or an intervertebral distance.
Measured: 5 minutes
Distance Between Dural Sac Termination Level And Placement Of Caudal Epidural Needle
Distance Between Dural Sac Termination Level And Placement Of Caudal Epidural Needle will be measured under longitudinal ultrasound view
Measured: 5 minutes
Definition Of Average Caudal Epidural Depth By Ultrasonography
Definition of caudal epidural depth by ultrasonography will be obtained under transverse view for every patient and average value will be defined for every age group.
Measured: 5 minutes
Secondary outcomes (1)
Determination Of Sacral Cornua As An Anatomic Landmark And Confirmation By Ultrasonography
Sacral cornua will be palpated and than will be scanned under transverse ultrasound view. Also results will be compared.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start28 Jan 2019
- Primary completion30 Dec 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, CaudalStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 348 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Pinar Kendigelen, Ayse Cigdem Tutuncu, Kaya, Guner, M.D.
- Responsible party
- Principal investigator, Celal Kaya, Istanbul University
- Investigators
- Celal Kaya, MD, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825172
- Sponsor's protocol ID
- 72109855-604.01.01-103424
- Status last verified
- Apr 2021
- First submitted
- 24 Jan 2019
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Caudal Epidural Anatomy By Ultrasonography İn Pediatric Patients
- ClinicalTrials.gov ID
- NCT03825172
- Acronym / sponsor ID
- 72109855-604.01.01-103424
- Conditions
- Anesthesia, Caudal, Anatomy, Ultrasonography, Pediatrics
- Keywords
- Caudal block, Ultrasound, Children, Regional block anatomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Pinar Kendigelen, Ayse Cigdem Tutuncu, Kaya, Guner, M.D.
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 31 Jan 2019 (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.
Detailed study of ultrasonographic caudal epidural anatomy
Detailed description
Caudal epidural block is one of the most common methods to provide analgesia for an infraumbilical surgery in children. Although it can be carried out safely and easily, many complications have been described so far, because of inaccurate needle injections. To perform a successful block, a good caudal epidural anatomic assessment is essential. Ultrasonography is an important tool to perform pediatric regional blocks, including caudal blocks. We believe that caudal epidural ultrasound evaluation can be an important option to decrease complications and to achieve a successful attempt; due to that we will try to describe caudal epidural ultrasound imaging and changes from one month to 84 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Diagnostic Test: Caudal Epidural UltrasonographyCaudal Epidural Ultrasonography will be performed in patients aged between 1-24 months |
| Group II | – | Diagnostic Test: Caudal Epidural UltrasonographyCaudal Epidural Ultrasonography will be performed in patients aged between 25-48 months |
| Group III | – | Diagnostic Test: Caudal Epidural UltrasonographyCaudal Epidural Ultrasonography will be performed in patients aged between 49-84 months |
Who may qualify
- Ages
- 1 month to 84 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients who are admitted to operating room for any pediatric surgery
Key inclusion criteria (1 listed)
- Pediatric patients who applied for any pediatric surgery from 20 january to 20 july
Key exclusion criteria (4 listed)
- Premature patients
- Patients who have any sendromic diagnosis
- Patients who have any musculoskeletal abnormalities
- Patients who have any spinal abnormalities
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 |
|---|---|---|
| Caudal Epidural UltrasonographyUltrasonographic Measurement | Diagnostic test | Group I, Group II, Group III |
Primary outcome
Definition Of Dural Sac Termination Level By Ultrasonography
Time frame: 5 minutes
After general anesthesia, patient will be placed in lateral decubitus position. First, a 12 MHz lineer ultrasound transducer will be placed transversely to obtain the transverse view of sacral hiatus; in this view we will try to show two sacral cornua, sacrococcygeal ligament, posterior sacral bone and caudal epidural depth. Secondly, transducer will be turned parallel to the midline or paravertebral to obtain longitudinal view; in longitudinal view we will try to obtain the images of sacral vertebral corpuses, caudal epidural area and dural sac. We will try to determine the level of dural sac termination according to a part of vertabral corpus or an intervertebral distance.
Distance Between Dural Sac Termination Level And Placement Of Caudal Epidural Needle
Time frame: 5 minutes
Distance Between Dural Sac Termination Level And Placement Of Caudal Epidural Needle will be measured under longitudinal ultrasound view
Definition Of Average Caudal Epidural Depth By Ultrasonography
Time frame: 5 minutes
Definition of caudal epidural depth by ultrasonography will be obtained under transverse view for every patient and average value will be defined for every age group.
1 secondary outcome
Determination Of Sacral Cornua As An Anatomic Landmark And Confirmation By Ultrasonography
Time frame: 5 minutes
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 11 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
Celal Kaya, MD principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Caudal and Anatomy, run by Istanbul 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 1 inclusion and 4 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 11 Jan 2022. 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?
Definition Of Dural Sac Termination Level By Ultrasonography (time frame: 5 minutes). The study lists 3 primary outcomes in all. 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 11 Jan 2022.