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

University of Florida

Status: Active, not recruiting

Conditions: Educational Problems

Treatments: Other: Single plane ultrasound; Other: Biplane Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT06319989

IRB202301905

Details and patient eligibility

About

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.

Full 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.

Enrollment: 281 estimated patients

Sex: Male

Ages: 4 months to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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281 participants in 2 patient groups

Biplane Ultrasound

Other group

Description:

The intervention group will receive caudal epidural block under the guidance of biplane ultrasound.

Treatment:

Other: Biplane Ultrasound

Single plane Ultrasound

Other group

Description:

The procedures for patients in the control group will be guided by conventional single-plane ultrasound.

Treatment:

Other: Single plane ultrasound