Pediatric Urologic SurgeriesNCT02345785
Evaluation of the Change of Penile Corpus Cavernosum After Caudal Block Using Ultrasonography in Children
An observational study of Pediatric Urologic Surgeries, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the change of penile corpus cavernosum after caudal block using ultrasonography in pediatric patient. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Pediatric Urologic Surgeries
- What is being tested?
- urologic surgery and caudal block
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Oct 2015to 22 Jan 2016
- 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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric patients who need urologic surgery and caudal block
Who may be able to join
- Twenty (ASA status I or II) children, ages 2 to 7 yr old, who were scheduled for a urologic surgery
- Children who needed caudal block for postoperative analgesia
Who cannot join
- if there were contraindications for caudal block including hypersensitivity to any local anaesthetics, bleeding diathesis, infections at the puncture sites, or pre-existing neurological disease.
- patients scheduled for penile surgery
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
The purpose of this study is to evaluate the change of penile corpus cavernosum after caudal block using ultrasonography in pediatric patient.
- Conditions
- Pediatric Urologic Surgeries
- Being tested
- urologic surgery and caudal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urologic surgery and caudal blockOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | pediatric patients who need urologic surgery and caudal block Receives: Other: urologic surgery and caudal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of penile corpus cavernosum
Evaluation of the change of penile corpus cavernosum after caudal block using ultrasonography in children
Measured: 1 min after LMA insertion
change of penile corpus cavernosum
Evaluation of the change of penile corpus cavernosum after caudal block using ultrasonography in children
Measured: 2 min after caudal block
change of penile corpus cavernosum
Evaluation of the change of penile corpus cavernosum after caudal block using ultrasonography in children
Measured: 5 min after caudal block
Secondary outcomes (3)
cavernosal arterial hemodynamics
Investigation of cavernosal arterial hemodynamics included peak systolic velocity [PS], end diastolic velocity [ED], mean velocity [MV], time-averaged maximum velocity [TAmax], time-averaged mean velocity [TAmean], pulsatility index [PI], volume flow [VF], and dorsalis pedis artery diameter [D].
Measured: 1 min after LMA insertion
cavernosal arterial hemodynamics
Investigation of cavernosal arterial hemodynamics included peak systolic velocity [PS], end diastolic velocity [ED], mean velocity [MV], time-averaged maximum velocity [TAmax], time-averaged mean velocity [TAmean], pulsatility index [PI], volume flow [VF], and dorsalis pedis artery diameter [D].
Measured: 2 min after caudal block
cavernosal arterial hemodynamics
Investigation of cavernosal arterial hemodynamics included peak systolic velocity [PS], end diastolic velocity [ED], mean velocity [MV], time-averaged maximum velocity [TAmax], time-averaged mean velocity [TAmean], pulsatility index [PI], volume flow [VF], and dorsalis pedis artery diameter [D].
Measured: 5 min after caudal block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study start2 Oct 2015
- Primary completion22 Jan 2016
- Study completion22 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Urologic SurgeriesStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 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
- NCT02345785
- Sponsor's protocol ID
- 4-2014-0891
- Status last verified
- Feb 2019
- First submitted
- 12 Jan 2015
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Change of Penile Corpus Cavernosum After Caudal Block Using Ultrasonography in Children
- ClinicalTrials.gov ID
- NCT02345785
- Acronym / sponsor ID
- 4-2014-0891
- Conditions
- Pediatric Urologic Surgeries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 2 Oct 2015
- Primary completion
- 22 Jan 2016 (actual)
- Study completion
- 22 Jan 2016 (actual)
- First posted
- 26 Jan 2015 (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.
The purpose of this study is to evaluate the change of penile corpus cavernosum after caudal block using ultrasonography in pediatric patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: urologic surgery and caudal blockpediatric patients who need urologic surgery and caudal block |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric patients who need urologic surgery and caudal block
Key inclusion criteria (2 listed)
- Twenty (ASA status I or II) children, ages 2 to 7 yr old, who were scheduled for a urologic surgery
- Children who needed caudal block for postoperative analgesia
Key exclusion criteria (2 listed)
- if there were contraindications for caudal block including hypersensitivity to any local anaesthetics, bleeding diathesis, infections at the puncture sites, or pre-existing neurological disease.
- patients scheduled for penile surgery
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 |
|---|---|---|
| urologic surgery and caudal block | Other | Group 1 |
Primary outcome
change of penile corpus cavernosum
Time frame: 1 min after LMA insertion
Evaluation of the change of penile corpus cavernosum after caudal block using ultrasonography in children
change of penile corpus cavernosum
Time frame: 2 min after caudal block
Evaluation of the change of penile corpus cavernosum after caudal block using ultrasonography in children
change of penile corpus cavernosum
Time frame: 5 min after caudal block
Evaluation of the change of penile corpus cavernosum after caudal block using ultrasonography in children
3 secondary outcomes
cavernosal arterial hemodynamics
Time frame: 1 min after LMA insertion
cavernosal arterial hemodynamics
Time frame: 2 min after caudal block
cavernosal arterial hemodynamics
Time frame: 5 min after 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 26 Feb 2019.
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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 Pediatric Urologic Surgeries, 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 2 inclusion and 2 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 26 Feb 2019. 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?
change of penile corpus cavernosum (time frame: 1 min after LMA insertion). 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 26 Feb 2019.