Caudal Epidural BlockNCT04039295
Estimation of Injection Volume for Caudal Epidural Block Using Dynamic US Imaging in Children
An observational study of Caudal Epidural Block, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Caudal epidural block is the most commonly used technique for analgesia in pediatric patients. Although there are clinically used doses of local anesthetics for caudal epidural block, we do not know exactly how much levels are blocked in young children. Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Caudal Epidural Block
- What is being tested?
- ultrasound guided caudal epidural block
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jul 2019to 14 Mar 2020
- 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 6 to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Among the patients who are scheduled to undergo elective polydactyly / syndactyly / polysyndactyly correction surgery in Asan Medical Center, the patients who meet the inclusion criteria are included.
Who may be able to join
- age: 6-24months
- ASA 1-3
- body weight: 5-20kg
Who cannot join
- patients who refuse to participate
- local site infection, pilonidal cyst, spina bifida
- spinal/meningeal abnormality
- patients who discharge after surgery without admission
- patients who is judged ineligible for other reasons by the authors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimation of Injection Volume for Caudal Epidural Block Using Dynamic Ultrasound Imaging in Young Pediatric Patients: an Observational Study
Caudal epidural block is the most commonly used technique for analgesia in pediatric patients. Although there are clinically used doses of local anesthetics for caudal epidural block, we do not know exactly how much levels are blocked in young children. Thus, we aimed to identify the spreading of injection of local anesthetics for caudal epidural block using ultrasound imaging in young children.
- Conditions
- Caudal Epidural Block
- Being tested
- ultrasound guided caudal epidural block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided caudal epidural blockProcedure or surgery
dynamic ultrasound imaging of the spread of local anesthetics
What is being measured
The primary outcome is the main question the study is designed to answer.
Required volume of local anesthetics
Required volume of local anesthetics to reach each level
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start24 Jul 2019
- Primary completion13 Mar 2020
- Study completion14 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caudal Epidural BlockStudies of the same condition, open and under way.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajung Kim, Asan Medical Center
- Investigators
- Hyungtae Kim, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039295
- Sponsor's protocol ID
- 2019-0750
- Status last verified
- Jun 2020
- First submitted
- 24 Jul 2019
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim HJ, Kim H, Lee S, Koh WU, Park SS, Ro Y. Reconsidering injection volume for caudal epidural block in young pediatric patients: a dynamic flow tracking experimental study. Reg Anesth Pain Med. 2024 May 7;49(5):355-360. doi: 10.1136/rapm-2023-104409.
PubMed 37429622
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Injection Volume for Caudal Epidural Block Using Dynamic Ultrasound Imaging in Young Pediatric Patients: an Observational Study
- ClinicalTrials.gov ID
- NCT04039295
- Acronym / sponsor ID
- 2019-0750
- Conditions
- Caudal Epidural Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 14 Mar 2020 (actual)
- First posted
- 31 Jul 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.
Caudal epidural block is the most commonly used technique for analgesia in pediatric patients. Although there are clinically used doses of local anesthetics for caudal epidural block, we do not know exactly how much levels are blocked in young children. Thus, we aimed to identify the spreading of injection of local anesthetics for caudal epidural block using ultrasound imaging in young children.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Among the patients who are scheduled to undergo elective polydactyly / syndactyly / polysyndactyly correction surgery in Asan Medical Center, the patients who meet the inclusion criteria are included.
Key inclusion criteria (3 listed)
- age: 6-24months
- ASA 1-3
- body weight: 5-20kg
Key exclusion criteria (5 listed)
- patients who refuse to participate
- local site infection, pilonidal cyst, spina bifida
- spinal/meningeal abnormality
- patients who discharge after surgery without admission
- patients who is judged ineligible for other reasons by the authors
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 guided caudal epidural blockdynamic ultrasound imaging of the spread of local anesthetics | Procedure or surgery | – |
Primary outcome
Required volume of local anesthetics
Time frame: 1 day
Required volume of local anesthetics to reach each level
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 16 Jun 2020.
- Derived from this study: PubMed 37429622Kim HJ, Kim H, Lee S, Koh WU, Park SS, Ro Y. Reconsidering injection volume for caudal epidural block in young pediatric patients: a dynamic flow tracking experimental study. Reg Anesth Pain Med. 2024 May 7;49(5):355-360. doi: 10.1136/rapm-2023-104409.
- Individual participant dataSharing planned: Undecided
Related trials for Caudal Epidural Block
RecruitingObservational study
Comparison of Erector Spinae Plane Block and Caudal Block for Postoperative Analgesia in Pediatric Patients Undergoing Orchiopexy: A Prospective Observational Study
Caudal Epidural Anesthesia, Sacral Erector Spinae Plane Block
Not yet recruiting
Comparison of Erector Spinae Plane Block and Caudal Block in Pediatric Patients Aged 1 to 8 Years Undergoing Lower Abdominal Surgery
Caudal Epidural Anesthesia, Erector Spinae Plane Block
Active, not recruitingObservational study
Efficacy of Combining Caudal Epidural Steroid With Ganglion Impar Block in Chronic Coccydynia
Caudal Epidural Block, Coccygodynia
Not yet recruitingPhase 4
Perfusion Index in Caudal Epidural Anasthesia
Caudal Epidural Block
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.
Hyungtae Kim, MD, PhD principal investigator
Asan Medical Center
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 Caudal Epidural Block, run by Asan Medical Center 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 3 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 16 Jun 2020. 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?
Required volume of local anesthetics (time frame: 1 day). 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 NCT04039295, which also lists 1 linked publication.
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 16 Jun 2020; AzTrials last refreshed its copy on 30 Oct 2026.