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

NCT06319989 | Active Not Recruiting

• 1 other identifier: IRB202301905
• Study Type: interventional
• Target: 281
• Locations: 1 country
• Sites: 1

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.

Conditions

Educational Problems

Keywords

biplane ultrasound; Caudal epidural anesthesia; single plane ultrasound

Outcome Measures

Primary Outcomes (1)

• First puncture success

  The epidural is obtained on first attempt.

  1 day

Secondary Outcomes (3)

• Number of Needle redirections

  1day

• Duration of epidural

  1 day

• Postoperative analgesic use

  24 hours post-op

Study Arms (2)

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

Biplane Ultrasound OTHER

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

Biplane Ultrasound

Single plane ultrasound OTHER

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

Single plane Ultrasound

Eligibility Criteria

• Age: 4 Months - 10 Years
• Gender Eligibility Details: Only male patients would be undergoing elective circumcision with caudal epidural anesthesia as an adjuvant to general anesthesia and for postoperative analgesia.
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health

Gainesville, Florida, 32610, United States

Location

Study Officials

• Sonia Mehta, MS

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, parallel study to assess the efficacy of biplane ultrasound-guided caudal epidural anesthesia in pediatric patients.

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: August 22, 2024
• Primary Completion: March 25, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

US (1)