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

Not Applicable

Recruiting

• Conditions: Educational Problems
• Interventions: Other: Single plane ultrasound; Other: Biplane Ultrasound

• Registration Number: NCT06319989
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-20
• Status Verified: 2024-08
• Study Start: 2024-08-22
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29
• Primary Completion: 2026-03-25
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 281

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
First puncture success	1 day	The epidural is obtained on first attempt.

Secondary Outcome Measures

Name	Time	Method
Postoperative analgesic use	24 hours post-op	The time from arriving at PACU to first postoperative analgesics use within 24 hours after discharge (continuous outcome, measured in hour).
Duration of epidural	1 day	Duration from placing the US probe on skin to successful injection (continuous outcome, measured in second).
Number of Needle redirections	1day	Redirection was defined as pulling the needle back and changing the direction without exiting the skin.

Trial Locations

Locations (1)

UF Health; 🇺🇸 Gainesville, Florida, United States