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

Educational Problems Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06319989
• Other study ID #: IRB202301905
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 25, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: March 2024
• Source: University of Florida
• Contact: Sonia Mehta, MD
• Phone: 352-273-7094
• Email: sdeshmukh[@]anest.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 281
• Est. completion date: September 30, 2026
• Est. primary completion date: March 25, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 4 Months to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Educational Problems

Intervention

Other:
• Biplane Ultrasound
During a standard of care caudal epidural block, biplane ultrasound will be used.
• Single plane ultrasound
During a standard of care caudal epidural block, single plane ultrasound will be used.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First puncture success	The epidural is obtained on first attempt.	1 day
Secondary	Number of Needle redirections	Redirection was defined as pulling the needle back and changing the direction without exiting the skin.	1day
Secondary	Duration of epidural	Duration from placing the US probe on skin to successful injection (continuous outcome, measured in second).	1 day
Secondary	Postoperative analgesic use	The time from arriving at PACU to first postoperative analgesics use within 24 hours after discharge (continuous outcome, measured in hour).	24 hours post-op