Skip to main content
OpenTrials
Completed

NCT Number: NCT06319989

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

4 month–10 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UF Health

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biplane Ultrasound

Other

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

Single plane ultrasound

Other

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

Primary outcomes

  1. First puncture success

    Time frame: 1 day

    The epidural is obtained on first attempt.

Secondary outcomes

  1. Number of Needle redirections

    Time frame: 1day

    Redirection was defined as pulling the needle back and changing the direction without exiting the skin.

  2. Duration of epidural

    Time frame: 1 day

    Duration from placing the US probe on skin to successful injection (continuous outcome, measured in second).

  3. Postoperative analgesic use

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.