HypospadiasNCT07615335
Comparison Between Ultrasound Guided Caudal Block and Ultrasound Guided Dorsal Penile Block in Hypospadias Surgery in Children
A study testing Caudal Block Anesthesia and Dorsal Penile Block Anesthesia in people with Hypospadias and Hypospadias, Coronal, run by Ahmed Aouf at 1 site in Egypt.
Trial summary
The study focuses on comparing the caudal block (CB) and the dorsal penile nerve block (DPNB) via ultrasound guidance in regional anesthesia in hypospadias surgery. Read more about this study
- Who is it for?
- Ages 1 year to 6 years, men only
- Conditions the study is for
- Hypospadias, Hypospadias, Coronal
- What is being tested?
- Caudal Block Anesthesia and Dorsal Penile Block Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Feb 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 6 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- It included male children who underwent hypospadias surgery (distal or mid penile) from 1 to 6 years old with American Society of Anesthesiologists (ASA) classification 1 or 2.
Who cannot join
- children older than 6 years and younger than 1 year.
- children with neurological, mental, and intellectual problems
- bleeding tendency
- allergy to any local anesthesia
- contraindications to regional anesthesia, back anomalies
- liver diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Ultrasound Guided Caudal and Dorsal Penile Block After Hypospadias Surgery in Children, A Randomized Clinical Trial
The study focuses on comparing the caudal block (CB) and the dorsal penile nerve block (DPNB) via ultrasound guidance in regional anesthesia in hypospadias surgery.
- Conditions
- Hypospadias, Hypospadias, Coronal
- Being tested
- Caudal Block Anesthesia, Dorsal Penile Block Anesthesia
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal Block AnesthesiaProcedure or surgery
Patients were positioned laterally for the procedure. The ultrasound transducer was first positioned transversely at the midline to visualize the sacral cornua, sacrococcygeal ligament, sacral bone, and sacral hiatus in a transverse view. It was then rotated 90° to obtain a longitudinal view of the sacrococcygeal ligament and sacral hiatus. A 22G, 50 mm needle was inserted caudal to cranial into the sacral canal under direct real-time longitudinal ultrasound guidance
Dorsal Penile Block AnesthesiaProcedure or surgery
With the patient in a supine position, using aseptic precautions, a linear probe (6-13 MHz) was placed transversely at the root of the penis. The penis was held under gentle traction, and key anatomical structures, including the corpus cavernosum, corpus spongiosum, dorsal artery and vein, Buck's fascia, and tunica albuginea, were identified in the transverse plane
| Study group | Role | What they receive |
|---|---|---|
| Dorsal penile nerve block group | Active comparator | Patients that had regional anesthesia using dorsal penile nerve block Receives: Procedure: Dorsal Penile Block Anesthesia |
| Caudal epidural block group | Active comparator | Patients that had regional anesthesia using caudal epidural block Receives: Procedure: Caudal Block Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue analgesia in hours
The time interval (measured in hours) from a specific starting point until the patient requires their first dose of additional pain medication (the "rescue" dose).
Measured: From surgery time to the next day after surgery.
Intraoperative Fentanyl dose
Measured: During the operations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Sep 2023
- Primary completion1 Jan 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Aouf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Aouf, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615335
- Sponsor's protocol ID
- KFSIRB200-1115
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin Z, Shao Y, Li H, Chen Z, Li Y, Wu S, Liu N, Zhang Z. Comparing the analgesic effects of ultrasound-guided caudal block and dorsal penile nerve block in pediatric concealed penis correction surgery: a randomized controlled trial. Front Pediatr. 2025 Jul 24;13:1607309. doi: 10.3389/fped.2025.1607309. eCollection 2025.
PubMed 40777159Kumari S, Kumar M, Sinha M, Singha SK, Gupta H, Dubey R. A Comparison of the Ultrasound-Guided Dorsal Penile Block and Ultrasound-Guided Caudal Epidural Block for Postoperative Analgesia in Children Undergoing Hypospadias Surgery: A Randomized Controlled Study. Cureus. 2025 Apr 16;17(4):e82351. doi: 10.7759/cureus.82351. eCollection 2025 Apr.
PubMed 40385755
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasound Guided Caudal and Dorsal Penile Block After Hypospadias Surgery in Children, A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07615335
- Acronym / sponsor ID
- KFSIRB200-1115
- Conditions
- Hypospadias, Hypospadias, Coronal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ahmed AoufUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 29 May 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.
The study focuses on comparing the caudal block (CB) and the dorsal penile nerve block (DPNB) via ultrasound guidance in regional anesthesia in hypospadias surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dorsal penile nerve block group | Active comparator | Procedure: Dorsal Penile Block AnesthesiaPatients that had regional anesthesia using dorsal penile nerve block |
| Caudal epidural block group | Active comparator | Procedure: Caudal Block AnesthesiaPatients that had regional anesthesia using caudal epidural block |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- It included male children who underwent hypospadias surgery (distal or mid penile) from 1 to 6 years old with American Society of Anesthesiologists (ASA) classification 1 or 2.
Key exclusion criteria (6 listed)
- children older than 6 years and younger than 1 year.
- children with neurological, mental, and intellectual problems
- bleeding tendency
- allergy to any local anesthesia
- contraindications to regional anesthesia, back anomalies
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 |
|---|---|---|
| Caudal Block AnesthesiaPatients were positioned laterally for the procedure. The ultrasound transducer was first positioned transversely at the midline to visualize the sacral cornua, sacrococcygeal ligament, sacral bone, and sacral hiatus in a transverse view. It was then rotated 90° to obtain a longitudinal view of the sacrococcygeal ligament and sacral hiatus. A 22G, 50 mm needle was inserted caudal to cranial into the sacral canal under direct real-time longitudinal ultrasound guidance | Procedure or surgery | Caudal epidural block group |
| Dorsal Penile Block AnesthesiaWith the patient in a supine position, using aseptic precautions, a linear probe (6-13 MHz) was placed transversely at the root of the penis. The penis was held under gentle traction, and key anatomical structures, including the corpus cavernosum, corpus spongiosum, dorsal artery and vein, Buck's fascia, and tunica albuginea, were identified in the transverse plane | Procedure or surgery | Dorsal penile nerve block group |
Primary outcome
Time to first rescue analgesia in hours
Time frame: From surgery time to the next day after surgery.
The time interval (measured in hours) from a specific starting point until the patient requires their first dose of additional pain medication (the "rescue" dose).
Intraoperative Fentanyl dose
Time frame: During the operations
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 14 Aug 2026.
- Background: PubMed 40777159Lin Z, Shao Y, Li H, Chen Z, Li Y, Wu S, Liu N, Zhang Z. Comparing the analgesic effects of ultrasound-guided caudal block and dorsal penile nerve block in pediatric concealed penis correction surgery: a randomized controlled trial. Front Pediatr. 2025 Jul 24;13:1607309. doi: 10.3389/fped.2025.1607309. eCollection 2025.
- Background: PubMed 40385755Kumari S, Kumar M, Sinha M, Singha SK, Gupta H, Dubey R. A Comparison of the Ultrasound-Guided Dorsal Penile Block and Ultrasound-Guided Caudal Epidural Block for Postoperative Analgesia in Children Undergoing Hypospadias Surgery: A Randomized Controlled Study. Cureus. 2025 Apr 16;17(4):e82351. doi: 10.7759/cureus.82351. eCollection 2025 Apr.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caudal Block Anesthesia and Dorsal Penile Block Anesthesia in people with Hypospadias and Hypospadias, Coronal, run by Ahmed Aouf at 1 site in Egypt.
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 1 inclusion and 6 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 14 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 Egypt. 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?
Time to first rescue analgesia in hours (time frame: From surgery time to the next day after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07615335, which also lists 2 linked publications.
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 14 Aug 2026.