Clinical trial NCT06319989: The Efficacy of Biplane Versus Single Plane Ultrasound in Facilitating Caudal Epidural Anesthesia in Pediatric Patients.
Official title: The Efficacy of Biplane Versus Single Plane Ultrasound in Facilitating Caudal Epidural Anesthesia in Pediatric Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Educational Problems
Keywords: biplane ultrasound
Caudal epidural anesthesia
single plane ultrasound
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 281
Sex: MALE
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, randomized, parallel study to assess the efficacy of biplane ultrasound-guided caudal epidural anesthesia in pediatric patients.
Primary purpose: OTHER

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: First puncture success
timeFrame: 1 day
Secondary outcomes:
measure: Number of Needle redirections
timeFrame: 1day
measure: Duration of epidural
timeFrame: 1 day
measure: Postoperative analgesic use
timeFrame: 24 hours post-op
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Sonia Mehta, MS
role: PRINCIPAL_INVESTIGATOR
References: