Children Who Need Urological SurgeryNCT01340313
Ultrasonographic Evaluation of Drug Spread in Epidural Space During Caudal Block in Children
An observational study of Children Who Need Urological Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
Caudal block is the world-widely used technique for an effective postoperative analgesia in children undergoing OPD-based infra-umbilical surgery. Because the caudal block is usually performed with a single-shot, proper dosage is required to achieve sufficient analgesic levels. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Children Who Need Urological Surgery
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2011to Aug 2011
- 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 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: 3 months old ~ 5 years old children undergoing minor infra-umbilical urological surgery
Who may be able to join
- children who needed caudal block for postoperative analgesia (age 3 months ~ 5 years old)
- Consent from one of parents 3. ASA physical status I or II
Who cannot join
- bleeding tendency
- spinal anomaly
- infection focus on back
- allergic reaction to local anesthetics
- foreigner of illiteracy who cannot read consent form
Trial locations and contacts
1 site in 1 country.
About this study
Caudal block is the world-widely used technique for an effective postoperative analgesia in children undergoing OPD-based infra-umbilical surgery. Because the caudal block is usually performed with a single-shot, proper dosage is required to achieve sufficient analgesic levels. Several clinical researches have been performed to assess the drug spread levels using mathematical equation, X-ray evaluation, and ultrasonography during caudal block in children. In our previous study using fluoroscopy, we obtained the results that the established weight-based doses provided adequate block levels for each type of surgery.
Ultrasonography is precise tool to evaluate the spinal structures and can provide estimated information in real time during caudal or epidural block in children.
The aim of this study is to evaluate the drug spread level with a weight-based doses using ultrasonography during caudal block in children and assess the reliability of the real time ultrasonography to determine the drug spread levels. After general anesthesia, the patient will be placed in lateral decubitus position for caudal block. Total 1.5 ml/kg of 0.15% ropivacaine will be injected into the caudal space. The spread level will be step-wise evaluated using ultrasonography at the injected drug dose of 0.5 ml/kg, 1.0 ml/kg, 1.25 ml/kg, and 1.5 ml/kg.
- Conditions
- Children Who Need Urological Surgery
- Keywords
- caudal block, children, ultrasound, urological surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 4 times evaluation according to doses in 1 group |
What is being measured
The primary outcome is the main question the study is designed to answer.
drug spread level with a weight-based doses
- spread levels of drug within the epidural space during drug injection with caudal block at every doses using real-time ultrasound examination.
- maximum spread levels within the epidural space
Measured: every 10 seconds for 1 minute during drug injection (10, 20, 30, 40, 50, and 60 seconds).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Children Who Need Urological SurgeryStudies 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
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hae Kum Kil, MD, MS, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340313
- Sponsor's protocol ID
- 4-2010-0775
- Status last verified
- Mar 2013
- First submitted
- 5 Apr 2011
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Hong JY, Han SW, Kim WO, Cho JS, Kil HK. A comparison of high volume/low concentration and low volume/high concentration ropivacaine in caudal analgesia for pediatric orchiopexy. Anesth Analg. 2009 Oct;109(4):1073-8. doi: 10.1213/ane.0b013e3181b20c52.
PubMed 19762734Shin SK, Hong JY, Kim WO, Koo BN, Kim JE, Kil HK. Ultrasound evaluation of the sacral area and comparison of sacral interspinous and hiatal approach for caudal block in children. Anesthesiology. 2009 Nov;111(5):1135-40. doi: 10.1097/ALN.0b013e3181bc6dd4.
PubMed 19809281Koo BN, Hong JY, Kil HK. Spread of ropivacaine by a weight-based formula in a pediatric caudal block: a fluoroscopic examination. Acta Anaesthesiol Scand. 2010 May;54(5):562-5. doi: 10.1111/j.1399-6576.2010.02224.x. Epub 2010 Mar 10.
PubMed 20236099Lundblad M, Lonnqvist PA, Eksborg S, Marhofer P. Segmental distribution of high-volume caudal anesthesia in neonates, infants, and toddlers as assessed by ultrasonography. Paediatr Anaesth. 2011 Feb;21(2):121-7. doi: 10.1111/j.1460-9592.2010.03485.x. Epub 2010 Dec 15.
PubMed 21159024
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of Drug Spread in Epidural Space During Caudal Block in Children
- ClinicalTrials.gov ID
- NCT01340313
- Acronym / sponsor ID
- 4-2010-0775
- Conditions
- Children Who Need Urological Surgery
- Keywords
- caudal block, children, ultrasound, urological surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 22 Apr 2011 (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 block is the world-widely used technique for an effective postoperative analgesia in children undergoing OPD-based infra-umbilical surgery. Because the caudal block is usually performed with a single-shot, proper dosage is required to achieve sufficient analgesic levels. Several clinical researches have been performed to assess the drug spread levels using mathematical equation, X-ray evaluation, and ultrasonography during caudal block in children. In our previous study using fluoroscopy, we obtained the results that the established weight-based doses provided adequate block levels for each type of surgery.
Ultrasonography is precise tool to evaluate the spinal structures and can provide estimated information in real time during caudal or epidural block in children.
The aim of this study is to evaluate the drug spread level with a weight-based doses using ultrasonography during caudal block in children and assess the reliability of the real time ultrasonography to determine the drug spread levels. After general anesthesia, the patient will be placed in lateral decubitus position for caudal block. Total 1.5 ml/kg of 0.15% ropivacaine will be injected into the caudal space. The spread level will be step-wise evaluated using ultrasonography at the injected drug dose of 0.5 ml/kg, 1.0 ml/kg, 1.25 ml/kg, and 1.5 ml/kg.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –4 times evaluation according to doses in 1 group |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 3 months old ~ 5 years old children undergoing minor infra-umbilical urological surgery
Key inclusion criteria (2 listed)
- children who needed caudal block for postoperative analgesia (age 3 months ~ 5 years old)
- Consent from one of parents 3. ASA physical status I or II
Key exclusion criteria (5 listed)
- bleeding tendency
- spinal anomaly
- infection focus on back
- allergic reaction to local anesthetics
- foreigner of illiteracy who cannot read consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
drug spread level with a weight-based doses
Time frame: every 10 seconds for 1 minute during drug injection (10, 20, 30, 40, 50, and 60 seconds).
1. spread levels of drug within the epidural space during drug injection with caudal block at every doses using real-time ultrasound examination. 2. maximum spread levels within the epidural space
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 6 Mar 2013.
- Background: PubMed 19762734Hong JY, Han SW, Kim WO, Cho JS, Kil HK. A comparison of high volume/low concentration and low volume/high concentration ropivacaine in caudal analgesia for pediatric orchiopexy. Anesth Analg. 2009 Oct;109(4):1073-8. doi: 10.1213/ane.0b013e3181b20c52.
- Background: PubMed 19809281Shin SK, Hong JY, Kim WO, Koo BN, Kim JE, Kil HK. Ultrasound evaluation of the sacral area and comparison of sacral interspinous and hiatal approach for caudal block in children. Anesthesiology. 2009 Nov;111(5):1135-40. doi: 10.1097/ALN.0b013e3181bc6dd4.
- Background: PubMed 20236099Koo BN, Hong JY, Kil HK. Spread of ropivacaine by a weight-based formula in a pediatric caudal block: a fluoroscopic examination. Acta Anaesthesiol Scand. 2010 May;54(5):562-5. doi: 10.1111/j.1399-6576.2010.02224.x. Epub 2010 Mar 10.
- Background: PubMed 21159024Lundblad M, Lonnqvist PA, Eksborg S, Marhofer P. Segmental distribution of high-volume caudal anesthesia in neonates, infants, and toddlers as assessed by ultrasonography. Paediatr Anaesth. 2011 Feb;21(2):121-7. doi: 10.1111/j.1460-9592.2010.03485.x. Epub 2010 Dec 15.
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.
Hae Kum Kil, MD, MS principal investigator
Severance Hospital
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 Children Who Need Urological Surgery, 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 5 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 6 Mar 2013. 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?
drug spread level with a weight-based doses (time frame: every 10 seconds for 1 minute during drug injection (10, 20, 30, 40, 50, and 60 seconds).). 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 NCT01340313, which also lists 4 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 6 Mar 2013.