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

NCT ID: NCT06319989

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 281 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-22
• Study Completion Date: 2026-09-30

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Biplane Ultrasound

The intervention group will receive caudal epidural block under the guidance of biplane ultrasound.

Group Type: OTHER

Biplane Ultrasound

Intervention Type: OTHER

During a standard of care caudal epidural block, biplane ultrasound will be used.

Single plane Ultrasound

The procedures for patients in the control group will be guided by conventional single-plane ultrasound.

Group Type: OTHER

Single plane ultrasound

Intervention Type: OTHER

During a standard of care caudal epidural block, single plane ultrasound will be used.

Interventions

Biplane Ultrasound

During a standard of care caudal epidural block, biplane ultrasound will be used.

Intervention Type: OTHER

Single plane ultrasound

During a standard of care caudal epidural block, single plane ultrasound will be used.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ASA I/II
• 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.

• Minimum Eligible Age: 4 Months
• Maximum Eligible Age: 10 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sonia Mehta, MS

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB202301905

Identifier Type: -

Identifier Source: org_study_id