Sacrococcygeal DisorderNCT04861935
Ultrasound Guided Investigation Of The Anatomical Features For Caudal Block In Children With Sacral Dimple
A study testing ultrasound evaluation in people with Sacrococcygeal Disorder, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
When dimples are detected in the sacral region, most practitioners consider it to be a sign of spinal anomaly and avoid caudal block. Ultrasound guided investigation of the anatomical features for caudal block in normal children and in children with sacral dimple will be informative for practitioners. Read more about this study
- Who is it for?
- Ages 1 month to 72 monthsHealthy volunteers can take part
- Conditions the study is for
- Sacrococcygeal Disorder
- What is being tested?
- ultrasound evaluation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2022to 11 Feb 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 1 month to 72 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- -Children aged 1-72 months who are taken to the operating room for any reason
Who cannot join
- spinal anomalies,
- history of prematurity,
- neurological disorder
- syndromic illness.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa
Istanbul, 34000
About this study
When dimples are detected in the sacral region, most practitioners consider it to be a sign of spinal anomaly and avoid caudal block. Ultrasound guided investigation of the anatomical features for caudal block in normal children and in children with sacral dimple will be informative for practitioners.
Read the detailed description
A dimple over the sacrum may be an isolated finding or a sign of underlying spinal abnormality. Therefore, most practitioners are confused to perform a caudal block. Ultrasonography is a safe and cost effective screening tool in pediatric patients. Ultrasound guided investigation of the anatomical features of sacral region may play a key role to eliminate suspicions. It is possible to detect spinal abnormalities and also measuring dural sac level, distance between dural sac and estimated needle insertion site or needle entry angle. In this study, we will examine whether there is a difference between normal children and children with dimple in the sacral region.
- Conditions
- Sacrococcygeal Disorder
- Being tested
- ultrasound evaluation
- Keywords
- pediatric, sacral dimple, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound evaluationDevice
ultrasound evaluation of normal patients and patients who have a sacral dimple
| Study group | Role | What they receive |
|---|---|---|
| ultrasound evaluation of sacral region in normal pediatric patients | Placebo comparator | Ultrasound evaluation of sacral region will be performed to detect spinal abnormality.
Dural sac level and its distance to estmated injection site, optimal entry angle for caudal block will be measured. Receives: Device: ultrasound evaluation |
| ultrasound evaluation of sacral region in patients with sacral dimple | Active comparator | Ultrasound evaluation of sacral region will be performed to detect spinal abnormality.
Dural sac level and its distance to estmated injection site, optimal entry angle for caudal block will be measured. Receives: Device: ultrasound evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound measurement-1
Dural sac level (mm)
Measured: 1 min
ultrasound measurement-2
distance between injection site and dural sac(mm)
Measured: 1 min
ultrasound measurement-3
optimal entry angle (0-angle degree) for caudal block
Measured: 1 min
Secondary outcomes (1)
ultrasound evaluation of sacral region
searching for spinal abnormalites in patients with sacral dimple
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start11 Nov 2022
- Primary completion11 Feb 2023
- Study completion11 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sacrococcygeal DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups were formed as those with and without dimples in the sacral region.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celal Kaya, Istanbul University
- Investigators
- Guner Kaya, Prof., Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861935
- Sponsor's protocol ID
- 72109855-604.01.01-231115
- Status last verified
- Feb 2023
- First submitted
- 19 Apr 2021
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Schwartz D, Al-Najjar H, Connelly NR. Caudal block in a child with a sacral dimple utilizing ultrasonography. Paediatr Anaesth. 2011 Oct;21(10):1073-4. doi: 10.1111/j.1460-9592.2011.03621.x. No abstract available.
PubMed 21981093Choi JH, Lee T, Kwon HH, You SK, Kang JW. Outcome of ultrasonographic imaging in infants with sacral dimple. Korean J Pediatr. 2018 Jun;61(6):194-199. doi: 10.3345/kjp.2018.61.6.194. Epub 2018 Jun 25.
PubMed 29963103
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Investigation Of The Anatomical Features For Caudal Block In Children With Sacral Dimple
- ClinicalTrials.gov ID
- NCT04861935
- Acronym / sponsor ID
- 72109855-604.01.01-231115
- Conditions
- Sacrococcygeal Disorder
- Keywords
- pediatric, sacral dimple, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 11 Feb 2023 (actual)
- Study completion
- 11 Feb 2023 (actual)
- First posted
- 27 Apr 2021 (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.
When dimples are detected in the sacral region, most practitioners consider it to be a sign of spinal anomaly and avoid caudal block. Ultrasound guided investigation of the anatomical features for caudal block in normal children and in children with sacral dimple will be informative for practitioners.
Detailed description
A dimple over the sacrum may be an isolated finding or a sign of underlying spinal abnormality. Therefore, most practitioners are confused to perform a caudal block. Ultrasonography is a safe and cost effective screening tool in pediatric patients. Ultrasound guided investigation of the anatomical features of sacral region may play a key role to eliminate suspicions. It is possible to detect spinal abnormalities and also measuring dural sac level, distance between dural sac and estimated needle insertion site or needle entry angle. In this study, we will examine whether there is a difference between normal children and children with dimple in the sacral region.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups were formed as those with and without dimples in the sacral region.
| Arm | Type | Receives |
|---|---|---|
| ultrasound evaluation of sacral region in normal pediatric patients | Placebo comparator | Device: ultrasound evaluationUltrasound evaluation of sacral region will be performed to detect spinal abnormality. Dural sac level and its distance to estmated injection site, optimal entry angle for caudal block will be measured. |
| ultrasound evaluation of sacral region in patients with sacral dimple | Active comparator | Device: ultrasound evaluationUltrasound evaluation of sacral region will be performed to detect spinal abnormality. Dural sac level and its distance to estmated injection site, optimal entry angle for caudal block will be measured. |
Who may qualify
- Ages
- 1 month to 72 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -Children aged 1-72 months who are taken to the operating room for any reason
Key exclusion criteria (4 listed)
- spinal anomalies,
- history of prematurity,
- neurological disorder
- syndromic illness.
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 |
|---|---|---|
| ultrasound evaluationultrasound evaluation of normal patients and patients who have a sacral dimple | Device | ultrasound evaluation of sacral region in normal pediatric patients, ultrasound evaluation of sacral region in patients with sacral dimple |
Primary outcome
ultrasound measurement-1
Time frame: 1 min
Dural sac level (mm)
ultrasound measurement-2
Time frame: 1 min
distance between injection site and dural sac(mm)
ultrasound measurement-3
Time frame: 1 min
optimal entry angle (0-angle degree) for caudal block
1 secondary outcome
ultrasound evaluation of sacral region
Time frame: 10 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 24 Feb 2023.
- Background: PubMed 21981093Schwartz D, Al-Najjar H, Connelly NR. Caudal block in a child with a sacral dimple utilizing ultrasonography. Paediatr Anaesth. 2011 Oct;21(10):1073-4. doi: 10.1111/j.1460-9592.2011.03621.x. No abstract available.
- Background: PubMed 29963103Choi JH, Lee T, Kwon HH, You SK, Kang JW. Outcome of ultrasonographic imaging in infants with sacral dimple. Korean J Pediatr. 2018 Jun;61(6):194-199. doi: 10.3345/kjp.2018.61.6.194. Epub 2018 Jun 25.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
Related trials for Sacrococcygeal Disorder
Recruiting
LASER VERSUS CRYSTALLIZED PHENOL IN PILONIDAL SINUS DISEASE
Sacrococcygeal Pilonidal Sinus Disease, Pilonidal Sinus Disease
Not yet recruitingObservational study
Screening LUMBAR Syndrome in Infants With Infantile Hemangiomas
LUMBAR Syndrome
Not yet recruitingObservational study
Effectiveness of Different Surgical Techniques for Curative Treatment of Pilonidal Sinus Disease in the Pediatric Population
Sacrococcygeal Pilonidal Sinus
Not yet recruiting
Silac Versus Phenol for the Treatment of Pilonidal Sinus Disease: A Randomized Controlled Trial
Pilonidal Sinus Disease
RecruitingObservational study
Bascom Cleft Lift for Primary Wound Healing in Complex and Recurrent Sacrococcygeal Pilonidal Sinus Disease
Pilonidal Sinus
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.
Guner Kaya, Prof. study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound evaluation in people with Sacrococcygeal Disorder, 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 24 Feb 2023. 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. Some participants in this study may receive a placebo. 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?
ultrasound measurement-1 (time frame: 1 min). 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?
On the ClinicalTrials.gov record for NCT04861935, which also lists 2 linked publications.
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 24 Feb 2023.