HydroceleNCT01896076
The Caudal Space in Children: Ultrasound Evaluation
An observational study of Hydrocele and Inguinal Hernia, run by Yonsei University at 1 site in South Korea.
Trial summary
Caudal anesthesia is commonly employed in pediatrics to produce postoperative analgesia in low abdominal or urologic surgery. An exact understanding of the anatomy of the sacral area including sacral hiatus and surrounding structures is crucial to the success of caudal block. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Hydrocele, Inguinal Hernia, Hypospadia
- What is being tested?
- ultrasound evaluation of caudal space
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Mar 2014
- 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 Up to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients aged 0 - 84 months who were scheduled to undergo elective urological surgery. This investigation was conducted at a single tertiary medical center (Severance Hospital), Seoul, Republic of Korea.
Who may be able to join
- Patients aged 0 - 84 months who were scheduled to undergo elective urological surgery.
Who cannot join
- Patients with any contraindication to caudal epidural block were excluded.
- coagulopathy
- allergy to local anesthetics
- infection at the puncture site
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 120-752
About this study
Caudal anesthesia is commonly employed in pediatrics to produce postoperative analgesia in low abdominal or urologic surgery.
An exact understanding of the anatomy of the sacral area including sacral hiatus and surrounding structures is crucial to the success of caudal block.
The aim of this study is to evaluate the anatomy of the caudal space in pediatrics by ultrasound evaluation.
- Conditions
- Hydrocele, Inguinal Hernia, Hypospadia, Cryptorchidism, Genitourinary Disease
- Being tested
- ultrasound evaluation of caudal space
- Keywords
- caudal space, children, ultrasound evaluation
- Medical subject headings
- Testicular Hydrocele, Hernia, Inguinal, Hypospadias, Cryptorchidism, Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound evaluation of caudal spaceOther
After induction of general anesthesia, the patients were placed in the lateral position. The ultrasound evaluation include transverse and longitudinal view.
First, investigators place the transducer at the sacral cornua to obtain a transverse view.
In the transverse view, the distance between two cornua and the depth of caudal space at the sacral hiatus were measured. In the longitudinal view, the distance from the skin to the sacrococcygeal membrane and the optimal angles and the safety distance for needle insertion depending on the points of insertions were measured. From the end of dura sac to the sacral hiatus were regarded as safety distance for the needle insertion during caudal block.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients in urologic surgery | Pediatric patients undergoing caudal block for urologic surgery were included in this study. Receives: Other: ultrasound evaluation of caudal space |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound evaluation of caudal space
First, investigators place the transducer at the sacral cornua to obtain a transverse view.
In the transverse view, the distance between two cornua and the depth of caudal space at the sacral hiatus were measured. In the longitudinal view, the distance from the skin to the sacrococcygeal membrane and the optimal angles and the safety distance for needle insertion depending on the points of insertions were measured. From the end of dura sac to the sacral hiatus were regarded as safety distance for the needle insertion during caudal block.
Measured: Right after induction of general anesthesia, the patients were placed in the lateral position. The ultrasound evaluation include transverse and longitudinal view.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydroceleStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896076
- Sponsor's protocol ID
- 4-2013-0244
- Status last verified
- Jul 2014
- First submitted
- 30 Jun 2013
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Caudal Space in Children: Ultrasound Evaluation
- ClinicalTrials.gov ID
- NCT01896076
- Acronym / sponsor ID
- 4-2013-0244
- Conditions
- Hydrocele, Inguinal Hernia, Hypospadia, Cryptorchidism, Genitourinary Disease
- Keywords
- caudal space, children, ultrasound evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 11 Jul 2013 (estimated)
- 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.
Caudal anesthesia is commonly employed in pediatrics to produce postoperative analgesia in low abdominal or urologic surgery.
An exact understanding of the anatomy of the sacral area including sacral hiatus and surrounding structures is crucial to the success of caudal block.
The aim of this study is to evaluate the anatomy of the caudal space in pediatrics by ultrasound evaluation.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients in urologic surgery | – | Other: ultrasound evaluation of caudal spacePediatric patients undergoing caudal block for urologic surgery were included in this study. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients aged 0 - 84 months who were scheduled to undergo elective urological surgery. This investigation was conducted at a single tertiary medical center (Severance Hospital), Seoul, Republic of Korea.
Key inclusion criteria (1 listed)
- Patients aged 0 - 84 months who were scheduled to undergo elective urological surgery.
Key exclusion criteria (4 listed)
- Patients with any contraindication to caudal epidural block were excluded.
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 evaluation of caudal spaceAfter induction of general anesthesia, the patients were placed in the lateral position. The ultrasound evaluation include transverse and longitudinal view. First, investigators place the transducer at the sacral cornua to obtain a transverse view. In the transverse view, the distance between two cornua and the depth of caudal space at the sacral hiatus were measured. In the longitudinal view, the distance from the skin to the sacrococcygeal membrane and the optimal angles and the safety distance for needle insertion depending on the points of insertions were measured. From the end of dura sac to the sacral hiatus were regarded as safety distance for the needle insertion during caudal block. | Other | Pediatric patients in urologic surgery |
Primary outcome
ultrasound evaluation of caudal space
Time frame: Right after induction of general anesthesia, the patients were placed in the lateral position. The ultrasound evaluation include transverse and longitudinal view.
First, investigators place the transducer at the sacral cornua to obtain a transverse view. In the transverse view, the distance between two cornua and the depth of caudal space at the sacral hiatus were measured. In the longitudinal view, the distance from the skin to the sacrococcygeal membrane and the optimal angles and the safety distance for needle insertion depending on the points of insertions were measured. From the end of dura sac to the sacral hiatus were regarded as safety distance for the needle insertion during caudal block.
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 28 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hydrocele and Inguinal Hernia, run by Yonsei University at 1 site in South Korea.
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 28 Jul 2014. 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 South Korea. 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?
ultrasound evaluation of caudal space (time frame: Right after induction of general anesthesia, the patients were placed in the lateral position. The ultrasound evaluation include transverse and longitudinal view.). 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 28 Jul 2014.