The Efficacy of Biplane Versus Single Plane Ultrasound in... | NCT06319989

Studies
The Efficacy of Biplane Versus Single Plane Ultrasound in Facilitating Caudal Epidural Anesthesia in Pediatric Patients.

NCT06319989

Sponsor

University of Florida

Status

Completed

Last Update Posted

May 8, 2026Actual

Enrollment

46Actual

Phase

Not Applicable

Conditions

Educational Problems

Interventions

Biplane Ultrasound
Single plane ultrasound

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 22, 2024Actual

Primary Completion Date

Dec 9, 2024Actual

Completion Date

Dec 9, 2024Actual

First Submitted Date

Mar 13, 2024

First Submission Date that Met QC Criteria

Mar 13, 2024

First Posted Date

Mar 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2026

Last Update Posted Date

May 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biplane Ultrasound	Other	The intervention group will receive caudal epidural block under the guidance of biplane ultrasound.	Other: Biplane Ultrasound
Single plane Ultrasound	Other	The procedures for patients in the control group will be guided by conventional single-plane ultrasound.	Other: Single plane ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biplane Ultrasound	Other	During a standard of care caudal epidural block, biplane ultrasound will be used.	Biplane Ultrasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
First puncture success	The epidural is obtained on first attempt.	1 day

Secondary Outcomes

Measure	Description	Time Frame
Number of Needle redirections	Redirection was defined as pulling the needle back and changing the direction without exiting the skin.	1day
Duration of epidural	Duration from placing the US probe on skin to successful injection (continuous outcome, measured in second).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Only male patients would be undergoing elective circumcision with caudal epidural anesthesia as an adjuvant to general anesthesia and for postoperative analgesia.

Minimum Age

4 Months

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sonia Mehta, MS	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UF Health		Gainesville	Florida	32610	United States

Masking Info

Masking

None (Open Label)

Masking Description

The intervention group will receive caudal epidural block under the guidance of biplane ultrasound. The procedures for patients in the control group will be guided by conventional single-plane ultrasound.

Who Masked

Not provided