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

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.

Study Overview

• Status: Completed
• Conditions: Educational Problems
• Intervention / Treatment: Other: Biplane Ultrasound; Other: Single plane ultrasound

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Biplane Ultrasound; The intervention group will receive caudal epidural block under the guidance of biplane ultrasound.	Other: Biplane Ultrasound; During a standard of care caudal epidural block, biplane ultrasound will be used.
Other: Single plane Ultrasound; The procedures for patients in the control group will be guided by conventional single-plane ultrasound.	Other: Single plane ultrasound; During a standard of care caudal epidural block, single plane ultrasound will be used.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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).	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).	24 hours post-op

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Sonia Mehta, MS, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2024
• Primary Completion (Actual): December 9, 2024
• Study Completion (Actual): December 9, 2024

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: biplane ultrasound; Caudal epidural anesthesia; single plane ultrasound
• Other Study ID Numbers: IRB202301905

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No