Postoperative PainNCT07426731
Comparison of Sacral ESP Block and Dorsal Penile Nerve Block in Pediatric Hypospadias Surgery
A study testing Sacral ESP Block Group and Dorsal Penile Nerve Block Group in people with Postoperative Pain and Hypospadias, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 7 years, men only
- Conditions the study is for
- Postoperative Pain, Hypospadias
- What is being tested?
- Sacral ESP Block Group and Dorsal Penile Nerve Block Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2026to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 7 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Postoperative Pain, Hypospadias
- Being tested
- Sacral ESP Block Group, Dorsal Penile Nerve Block Group
- Medical subject headings
- Pain, Postoperative, Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral ESP Block GroupProcedure or surgery
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
Dorsal Penile Nerve Block GroupProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Sacral ESP Block Group | Experimental | 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 Receives: Procedure: Sacral ESP Block Group |
| Dorsal Penile Nerve Block Group | Active comparator | 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. Receives: Procedure: Dorsal Penile Nerve Block Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score (FLACC) at 12 Hours
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.
Measured: 30 minutes, 1, 2, 4, 6, 12 and 24 hours post-surgery
Secondary outcomes (3)
Total Postoperative Analgesic Consumption
The cumulative amount of rescue analgesics (mg) consumed.
Measured: 24 hours post-surgery
Incidence of Postoperative Complications.
Presence of motor block, urinary retention, hematoma/ecchymosis at injection site, vomiting, or pruritus.
Measured: Up to 24 hours
Postoperative Pain Scores (FLACC) at Other Time Points
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.
Measured: 30 minutes, 1, 2, 4, 6, 12 and 24 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start20 Feb 2026
- Primary completion31 Jul 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- Biruni University, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Responsible party
- Principal investigator, Burak Omur, Medipol University
- Investigators
- Selçuk Alver, Study chair, Istanbul Biruni University Hospital, Istanbul, Turkey.Volkan Özen, Study chair, Prof. Dr. Cemil Tascioglu City Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426731
- Sponsor's protocol ID
- 149
- Status last verified
- Aug 2026
- First submitted
- 15 Feb 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07426731
- Acronym / sponsor ID
- 149
- Conditions
- Postoperative Pain, Hypospadias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Collaborators
- Biruni University, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacral ESP Block Group | Experimental | Procedure: Sacral ESP Block GroupPatients 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 |
| Dorsal Penile Nerve Block Group | Active comparator | Procedure: Dorsal Penile Nerve Block GroupPatients 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. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacral ESP Block GroupPatients 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 or surgery | Sacral ESP Block Group |
| Dorsal Penile Nerve Block GroupPatients 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 or surgery | Dorsal Penile Nerve Block Group |
Primary outcome
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.
3 secondary outcomes
Total Postoperative Analgesic Consumption
Time frame: 24 hours post-surgery
Incidence of Postoperative Complications.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selçuk Alver study chair
Istanbul Biruni University Hospital, Istanbul, Turkey.
Volkan Özen study chair
Prof. Dr. Cemil Tascioglu City Hospital, Istanbul, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral ESP Block Group and Dorsal Penile Nerve Block Group in people with Postoperative Pain and Hypospadias, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score (FLACC) at 12 Hours (time frame: 30 minutes, 1, 2, 4, 6, 12 and 24 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.