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Recruiting NCT07426731

NCT07426731 Comparison of Sacral ESP Block and Dorsal Penile Nerve Block in Pediatric Hypospadias Surgery

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Clinical Trial Summary
NCT ID NCT07426731
Status Recruiting
Phase
Sponsor Medipol University
Condition Postoperative Pain
Study Type INTERVENTIONAL
Enrollment 70 participants
Start Date 2026-02-13
Primary Completion 2026-04-01

Eligibility & Interventions

Sex Male only
Min Age 1 Year
Max Age 7 Years
Study Type INTERVENTIONAL
Interventions
Sacral ESP Block GroupDorsal Penile Nerve Block Group

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 70 participants in total. It began in 2026-02-13 with a primary completion date of 2026-04-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

This randomized controlled trial aims to compare the postoperative analgesic efficacy of ultrasound-guided Sacral Erector Spinae Plane (ESP) block versus Dorsal Penile Nerve Block (DPNB) in pediatric patients aged 1-7 years undergoing hypospadias surgery. The primary outcome is the pain score assessed by the FLACC scale at the 12th postoperative hour

Eligibility Criteria

Inclusion Criteria: * Pediatric male patients aged 1-7 years. * ASA (American Society of Anesthesiologists) physical status I or II. * Scheduled for elective hypospadias surgery. * Written informed consent obtained from parents/guardians Exclusion Criteria: * 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

Contact & Investigator

Central Contact

Burak Ömür

✉ bomur@medipol.edu.tr

📞 +905056215056

Principal Investigator

Selçuk Alver

STUDY CHAIR

Istanbul Biruni University Hospital, Istanbul, Turkey.

Frequently Asked Questions

Who can join the NCT07426731 clinical trial?

This trial is open to male participants only, aged 1 Year or older, up to 7 Years, studying Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07426731 currently recruiting?

Yes, NCT07426731 is actively recruiting participants. Contact the research team at bomur@medipol.edu.tr for enrollment information.

Where is the NCT07426731 trial being conducted?

This trial is being conducted at Istanbul, Turkey (Türkiye).

Who is sponsoring the NCT07426731 clinical trial?

NCT07426731 is sponsored by Medipol University. The principal investigator is Selçuk Alver at Istanbul Biruni University Hospital, Istanbul, Turkey.. The trial plans to enroll 70 participants.

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