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Procedure

Biplane vs Single Plane Ultrasound for Pediatric Epidural Anesthesia

N/A
Recruiting
Led By Sonia Mehta, MS
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours post-op
Awards & highlights
No Placebo-Only Group

Summary

This trial suggests that using biplane ultrasound for caudal epidural blocks in children may lead to better results compared to traditional ultrasound. Biplane ultrasound allows for better imaging and is expected to improve

Who is the study for?
This trial is for male pediatric patients aged 4 months to 10 years who are scheduled for elective circumcision and require caudal epidural anesthesia. They should be generally healthy (ASA I/II) and the anesthesia is used alongside general anesthesia for pain relief after surgery.
What is being tested?
The study compares two types of ultrasound guidance: single plane and biplane, in facilitating caudal epidural blocks during pediatric surgeries. The goal is to see if biplane ultrasound, which shows two views at once, leads to quicker procedures with fewer attempts needed and longer-lasting pain relief post-surgery.
What are the potential side effects?
While specific side effects are not listed, typical risks associated with ultrasound-guided procedures may include discomfort at the injection site or rare complications from incorrect needle placement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a boy between 4 months and 10 years old.
Select...
I am planning to have a circumcision with additional anesthesia for pain relief.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
First puncture success
Secondary study objectives
Duration of epidural
Number of Needle redirections
Postoperative analgesic use

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Single plane UltrasoundExperimental Treatment1 Intervention
The procedures for patients in the control group will be guided by conventional single-plane ultrasound.
Group II: Biplane UltrasoundExperimental Treatment1 Intervention
The intervention group will receive caudal epidural block under the guidance of biplane ultrasound.

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Who is running the clinical trial?

University of FloridaLead Sponsor
1,409 Previous Clinical Trials
767,178 Total Patients Enrolled
Sonia Mehta, MSPrincipal InvestigatorUniversity of Florida
~187 spots leftby Mar 2026
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