Comparing biplane and single plane ultrasound for pediatric epidural anesthesia
The Efficacy of Biplane Versus Single Plane Ultrasound in Facilitating Caudal Epidural Anesthesia in Pediatric Patients.
This study is testing whether using biplane ultrasound can help doctors give epidural anesthesia more accurately and quickly to children compared to using single-plane ultrasound.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 281 (estimated) |
| Ages | 4 Months to 10 Years |
| Sex | Male |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06319989 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of biplane ultrasound compared to single-plane ultrasound in guiding caudal epidural anesthesia in pediatric patients. By using a randomized approach, the research will assess metrics such as the first puncture success rate, procedure time, and postoperative analgesic use. The goal is to determine if biplane ultrasound can improve the accuracy and efficiency of the caudal block procedure. Safety evaluations will also be conducted to monitor any adverse events during and after the procedure.
Who should consider this trial
Good fit: Ideal candidates are male pediatric patients aged 4 months to 10 years who are ASA I/II and undergoing elective circumcision with caudal epidural anesthesia.
Not a fit: Patients with anatomical anomalies, coagulopathy, or those who are female will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved anesthesia techniques, resulting in better pain management and recovery for pediatric patients undergoing surgery.
How similar studies have performed: While the use of ultrasound in anesthesia is well-established, the specific comparison of biplane versus single-plane ultrasound in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gainesville, Florida
- UF Health — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Sonia Mehta, MS — University of Florida
- Study coordinator: Sonia Mehta, MD
- Email: sdeshmukh@anest.ufl.edu
- Phone: 352-273-7094
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.