Educational ProblemsNCT06319989
The Efficacy of Biplane Versus Single Plane Ultrasound in Facilitating Caudal Epidural Anesthesia in Pediatric Patients.
A study testing Biplane Ultrasound and Single plane ultrasound in people with Educational Problems, run by University of Florida at 1 site in United States.
Trial summary
Ultrasound guidance plays a pivotal role in caudal epidural block in pediatric patients. In comparison to conventional single-plane ultrasound, biplane ultrasound offers the advantage of providing simultaneous transverse and longitudinal imaging. Read more about this study
- Who is it for?
- Ages 4 months to 10 years, men only
- Conditions the study is for
- Educational Problems
- What is being tested?
- Biplane Ultrasound and Single plane ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2024to 9 Dec 2024
- 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 4 months to 10 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- ASA I/II (Anesthesia Physical Status Classification System)
- Male patients aged 4 months to 10 years
- To undergo elective circumcision with caudal epidural anesthesia as an adjuvant to general anesthesia and for postoperative analgesia
Who cannot join
- Anatomical anomalies (e.g., tethered cord, sacral malformations, etc.).
- Potential coagulopathy.
- Preoperative analgesics use.
- Allergy to local anesthetics.
- Rash or infection at the injection site.
- Female patients
- Parents refuse to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Ultrasound guidance plays a pivotal role in caudal epidural block in pediatric patients. In comparison to conventional single-plane ultrasound, biplane ultrasound offers the advantage of providing simultaneous transverse and longitudinal imaging. Better visualization under biplane ultrasound is postulated to enhance the efficacy of caudal epidural blocks. This improvement is expected to manifest through higher first puncture success rate, shorter procedure time, and longer time to first postoperative analgesics use.
Read the detailed description
Our study aims to recruit pediatric patients receiving caudal epidural blocks as a complement to general anesthesia and for postoperative analgesia. Through a randomized allocation, we will administer the caudal injection with either a biplane ultrasound-guided approach or the single-plane ultrasound-guided technique. The assessment will encompass accuracy metrics, such as the first puncture success rate and number of needle redirections, and the efficiency indicators, including the time from initial probe placement on the skin to successful injection, the time to first postoperative analgesics use, and PACU (post anesthesia care unit) pain score. Safety evaluation will be conducted, encompassing adverse events from the commencement of the caudal block procedure until discharge. We will also conduct post-discharge follow-up phone calls to evaluate patients' experience after discharge.
- Conditions
- Educational Problems
- Being tested
- Biplane Ultrasound, Single plane ultrasound
- Keywords
- biplane ultrasound, Caudal epidural anesthesia, single plane ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biplane UltrasoundOther
During a standard of care caudal epidural block, biplane ultrasound will be used.
Single plane ultrasoundOther
During a standard of care caudal epidural block, single plane ultrasound will be used.
| Study group | Role | What they receive |
|---|---|---|
| Biplane Ultrasound | Other | The intervention group will receive caudal epidural block under the guidance of biplane ultrasound. Receives: Other: Biplane Ultrasound |
| Single plane Ultrasound | Other | The procedures for patients in the control group will be guided by conventional single-plane ultrasound. Receives: Other: Single plane ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
First puncture success
The epidural is obtained on first attempt.
Measured: 1 day
Secondary outcomes (3)
Number of Needle redirections
Redirection was defined as pulling the needle back and changing the direction without exiting the skin.
Measured: 1day
Duration of epidural
Duration from placing the US probe on skin to successful injection (continuous outcome, measured in second).
Measured: 1 day
Postoperative analgesic use
The time from arriving at PACU to first postoperative analgesics use within 24 hours after discharge (continuous outcome, measured in hour).
Measured: 24 hours post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start22 Aug 2024
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ProblemsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, parallel study to assess the efficacy of biplane ultrasound-guided caudal epidural anesthesia in pediatric patients.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonia Mehta, MS, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319989
- Sponsor's protocol ID
- IRB202301905
- Status last verified
- Sep 2025
- First submitted
- 13 Mar 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Biplane Versus Single Plane Ultrasound in Facilitating Caudal Epidural Anesthesia in Pediatric Patients.
- ClinicalTrials.gov ID
- NCT06319989
- Acronym / sponsor ID
- IRB202301905
- Conditions
- Educational Problems
- Keywords
- biplane ultrasound, Caudal epidural anesthesia, single plane ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 20 Mar 2024 (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.
Ultrasound guidance plays a pivotal role in caudal epidural block in pediatric patients. In comparison to conventional single-plane ultrasound, biplane ultrasound offers the advantage of providing simultaneous transverse and longitudinal imaging. Better visualization under biplane ultrasound is postulated to enhance the efficacy of caudal epidural blocks. This improvement is expected to manifest through higher first puncture success rate, shorter procedure time, and longer time to first postoperative analgesics use.
Detailed description
Our study aims to recruit pediatric patients receiving caudal epidural blocks as a complement to general anesthesia and for postoperative analgesia. Through a randomized allocation, we will administer the caudal injection with either a biplane ultrasound-guided approach or the single-plane ultrasound-guided technique. The assessment will encompass accuracy metrics, such as the first puncture success rate and number of needle redirections, and the efficiency indicators, including the time from initial probe placement on the skin to successful injection, the time to first postoperative analgesics use, and PACU (post anesthesia care unit) pain score. Safety evaluation will be conducted, encompassing adverse events from the commencement of the caudal block procedure until discharge. We will also conduct post-discharge follow-up phone calls to evaluate patients' experience after discharge.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, parallel study to assess the efficacy of biplane ultrasound-guided caudal epidural anesthesia in pediatric patients.
| Arm | Type | Receives |
|---|---|---|
| Biplane Ultrasound | Other | Other: Biplane UltrasoundThe intervention group will receive caudal epidural block under the guidance of biplane ultrasound. |
| Single plane Ultrasound | Other | Other: Single plane ultrasoundThe procedures for patients in the control group will be guided by conventional single-plane ultrasound. |
Who may qualify
- Ages
- 4 months to 10 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I/II (Anesthesia Physical Status Classification System)
- Male patients aged 4 months to 10 years
- To undergo elective circumcision with caudal epidural anesthesia as an adjuvant to general anesthesia and for postoperative analgesia
Key exclusion criteria (7 listed)
- Anatomical anomalies (e.g., tethered cord, sacral malformations, etc.).
- Potential coagulopathy.
- Preoperative analgesics use.
- Allergy to local anesthetics.
- Rash or infection at the injection site.
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 |
|---|---|---|
| Biplane UltrasoundDuring a standard of care caudal epidural block, biplane ultrasound will be used. | Other | Biplane Ultrasound |
| Single plane ultrasoundDuring a standard of care caudal epidural block, single plane ultrasound will be used. | Other | Single plane Ultrasound |
Primary outcome
First puncture success
Time frame: 1 day
The epidural is obtained on first attempt.
3 secondary outcomes
Number of Needle redirections
Time frame: 1day
Duration of epidural
Time frame: 1 day
Postoperative analgesic use
Time frame: 24 hours post-op
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 8 May 2026.
Related trials for Educational Problems
Not yet recruiting
Standardized Educational Videos of Laparoscopic Gynecological Surgeries
Educational Problems, Surgery
Active, not recruiting
Impact of Surgical Coaching on Resident ObGyn Laparoscopic Skills
Educational Problems
Not yet recruiting
Evaluation of a Couple-based Psycho-socio-educational Intervention Using WeChat/WhatsApp on Dyadic Psychological and Sleep Outcomes
Sleep Problems, Psychological
Active, not recruiting
Fostering Healthy Futures for Teens: An RCT
Child Abuse, Child Neglect
Recruiting
Health Equity and Rural Education (HERE!) Clinical Trial
Behavioral Symptoms, Community Health Workers
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.
Sonia Mehta, MS principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biplane Ultrasound and Single plane ultrasound in people with Educational Problems, run by University of Florida at 1 site in United States.
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 7 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 8 May 2026. 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 United States. 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?
First puncture success (time frame: 1 day). 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 8 May 2026.