Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06319989
Enrollment
46
Registered
2024-03-20
Start date
2024-08-22
Completion date
2024-12-09
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Educational Problems

Keywords

biplane ultrasound, Caudal epidural anesthesia, single plane ultrasound

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 (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.

Interventions

OTHERBiplane Ultrasound

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

OTHERSingle plane ultrasound

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

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
MALE
Age
4 Months to 10 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
First puncture success1 dayThe epidural is obtained on first attempt.

Secondary

MeasureTime frameDescription
Number of Needle redirections1dayRedirection was defined as pulling the needle back and changing the direction without exiting the skin.
Duration of epidural1 dayDuration from placing the US probe on skin to successful injection (continuous outcome, measured in second).
Postoperative analgesic use24 hours post-opThe time from arriving at PACU to first postoperative analgesics use within 24 hours after discharge (continuous outcome, measured in hour).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSonia Mehta, MS

University of Florida

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026