NCT06319989

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 281 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: Male
• Age: 4 Months – 10 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Biplane Ultrasound	During a standard of care caudal epidural block, biplane ultrasound will be used.
OTHER	Single plane ultrasound	During a standard of care caudal epidural block, single plane ultrasound will be used.

Timeline

• Start date: 2024-08-22
• Primary completion: 2026-03-25
• Completion: 2026-09-30
• First posted: 2024-03-20
• Last updated: 2025-09-19

Locations

1 site across 1 country: United States