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

March 19, 2026 updated by: Burak Omur, Medipol University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Hypospadias surgery in pediatric patients can cause significant postoperative pain. While Dorsal Penile Nerve Block (DPNB) is a standard regional technique, the Sacral Erector Spinae Plane (ESP) block has emerged as a potential alternative for trunk and pelvic analgesia.

In this prospective, randomized, double-blind study, 70 pediatric patients (ASA I-II, aged 1-7 years) will be randomly assigned to receive either a Sacral ESP block or a DPNB under general anesthesia. Both blocks will be performed under ultrasound guidance using 0.25% bupivacaine, administered at a volume of 0.4 mL/kg for the Sacral ESP block and 0.4 mL/kg for the DPNB.

Postoperative pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale at 30 minutes, 1, 2, 6, 12, and 24 hours. The study aims to determine if Sacral ESP provides superior or non-inferior analgesia compared to DPNB, specifically focusing on the 12th-hour pain scores, total analgesic consumption, and time to first rescue analgesic

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sacral ESP Block Group
Patients will be placed in the lateral decubitus position. Under ultrasound guidance, the plane between the multifidus muscle and the sacral lamina (erector spinae plane) will be identified at the sacral level. A total of 0.4 mL/kg of 0.25% Bupivacaine will be injected bilaterally
Procedure: Sacral ESP Block Group
Patients will be placed in the lateral decubitus position. Under ultrasound guidance, the plane between the multifidus muscle and the sacral lamina (erector spinae plane) will be identified at the sacral level. A total of 0.4 mL/kg of 0.25% Bupivacaine will be injected bilaterally
Active Comparator: Dorsal Penile Nerve Block Group
Patients will be in the supine position. Under ultrasound guidance, the needle will be advanced under Buck's fascia at the penile base (pubic symphysis level). A total of 0.4 mL/kg of 0.25% Bupivacaine will be injected bilaterally.
Procedure: Dorsal Penile Nerve Block Group
Patients will be in the supine position. Under ultrasound guidance, the needle will be advanced under Buck's fascia at the penile base (pubic symphysis level). A total of 0.4 mL/kg of 0.25% Bupivacaine will be injected bilaterally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Score (FLACC) at 12 Hours
Time Frame: 30 minutes, 1, 2, 4, 6, 12 and 24 hours post-surgery
Pain severity assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale at 30 minutes, 1, 2, 4, 6, 12 and 24 hours. The total score ranges from 0 to 10, where higher scores indicate worse pain.
30 minutes, 1, 2, 4, 6, 12 and 24 hours post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Postoperative Analgesic Consumption
Time Frame: 24 hours post-surgery
The cumulative amount of rescue analgesics (mg) consumed.
24 hours post-surgery
Incidence of Postoperative Complications.
Time Frame: Up to 24 hours
Presence of motor block, urinary retention, hematoma/ecchymosis at injection site, vomiting, or pruritus.
Up to 24 hours
Postoperative Pain Scores (FLACC) at Other Time Points
Time Frame: 30 minutes, 1, 2, 4, 6, 12 and 24 hours post-surgery
Pain severity assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale at 30 minutes, 1, 2, 4, 6, 12 and 24 hours. The total score ranges from 0 to 10, where higher scores indicate worse pain.
30 minutes, 1, 2, 4, 6, 12 and 24 hours post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Collaborators

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Biruni University

Investigators

  • Study Chair: Selçuk Alver, Istanbul Biruni University Hospital, Istanbul, Turkey.
  • Study Chair: Volkan Özen, Prof. Dr. Cemil Tascioglu City Hospital, Istanbul, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

February 15, 2026

First Submitted That Met QC Criteria

February 15, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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