Comparison of Analgesic Efficacy of Sacral Erector Spinae Plane Block and Caudal Epidural Block i… (NCT07286786) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Analgesic Efficacy of Sacral Erector Spinae Plane Block and Caudal Epidural Block in Pediatric Patients Undergoing Hypospadias Surgery
Turkey (Türkiye)86 participantsStarted 2025-01-18
Plain-language summary
The goal of this observational study is to learn about effects of block strategies (sacral erector spinae plane block - ESP, caudal block) on perioperative pain in pediatric patients undergoing hypospadias surgery. The main question it aims to answer is:
Is there a difference in analgesic efficacy between sacral erector spinae plane block and caudal block in pediatric patients undergoing hypospadias surgery? Eighty six pediatric patients (ages 1-7 years, ASA I-II) scheduled for hypospadias repair under general anesthesia were included in this prospective randomized study. Both blocks were performed using 0.25% bupivacaine, at doses of 0.5 mL/kg for our study. Pain was assessed using the FLACC scale at 1, 2, 4, 6, 12 and 24 hours postoperatively.
Who can participate
Age range
1 Year – 7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children aged 1-7 years
* Classified as ASA physical status I-II
* Scheduled for primary hypospadias repair were enrolled
Exclusion Criteria:
* Infection at the injection site
* Coagulopathy
* Spinal anomalies
* Allergy to local anesthetics
* Parental refusal.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The pain status of patients in both groups will be evaluated with the FLACC score at postoperative 1, 2, 4, 6, 12 and 24 hours.
Timeframe: It will be evaluated at 1, 2, 4, 6, 12 and 24 hours postoperatively.
Trial details
NCT IDNCT07286786
SponsorProf. Dr. Cemil Tascıoglu Education and Research Hospital Organization