Actively Recruiting
Comparison of the Effects of Sacral Erector Spinae Plane Block and Dorsal Penile Nerve Block on Postoperative Pain Management in Pediatric Patients Undergoing Hypospadias Surgery
Led by Medipol University · Updated on 2026-03-20
70
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
M
Medipol University
Lead Sponsor
B
Biruni University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two methods for managing postoperative pain in boys aged 1 to 7 years undergoing hypospadias surgery. This study evaluates the pain relief effectiveness of an ultrasound-guided Sacral Erector Spinae Plane (ESP) block versus the standard Dorsal Penile Nerve Block (DPNB). The primary focus is on the pain score measured by the FLACC scale at 12 hours after surgery. Seventy pediatric patients will be randomly assigned to receive either the Sacral ESP block or the DPNB while under general anesthesia. Both procedures involve ultrasound guidance and use 0.25% bupivacaine at a dose of 0.4 mL per kilogram, administered bilaterally. The Sacral ESP block is performed with the patient in the side-lying position targeting the erector spinae plane at the sacral level, while the DPNB is done with the patient lying on their back, injecting under Buck's fascia at the penile base. Participants will have their postoperative pain assessed at multiple time points including 30 minutes, 1, 2, 6, 12, and 24 hours using the FLACC scale. Researchers will also monitor total analgesic use and any postoperative complications within 24 hours. The study includes careful pain and safety monitoring to evaluate which block provides better or comparable pain relief following hypospadias surgery.
CONDITIONS
Brief Title
Comparison of Sacral ESP Block and Dorsal Penile Nerve Block in Pediatric Hypospadias Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric male patients aged 1 to 7 years
- ASA physical status I or II
- Scheduled for elective hypospadias surgery
- Written informed consent obtained from parents or guardians
You will not qualify if you...
- History of neurological deficit or developmental delay
- Bleeding diathesis or known coagulopathy
- History of allergy to local anesthetics
- Infection or skin lesion at the block injection site
- Congenital spinal anomaly
- Mental retardation or history of psychiatric disease
- Liver or kidney dysfunction
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day
Participants undergo hypospadias surgery and receive either a Sacral ESP block or a Dorsal Penile Nerve Block under general anesthesia for postoperative pain management.
1 visit (in-person, day of surgery)
Duration - 24 hours post-surgery
Participants have their postoperative pain assessed using the FLACC scale at multiple time points within 24 hours after surgery and are monitored for analgesic consumption and complications.
Pain assessments at 30 minutes, 1, 2, 4, 6, 12, and 24 hours post-surgery
Trial Site Locations
Total: 1 location
1
Istanbul Medipol University
Istanbul, Turkey (Türkiye)
Actively Recruiting
Research Team
B
Burak Ömür
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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