New pain block study aims to ease surgery recovery for toddlers
NCT ID NCT07099560
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study compares two types of nerve blocks—sacral erector spinae plane block and caudal block—to see which provides better pain relief after hypospadias repair in boys aged 1 to 5. Seventy children will receive one of the two blocks along with standard care. Researchers will measure pain scores, need for extra pain medicine, and side effects over 24 hours after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bupivacaine
- What this could lead to
- If one block proves better, it could lead to improved pain control and fewer side effects for young boys after hypospadias repair.
- What could go wrong
- This is a small, early-stage trial with only 70 participants, so results may not apply to all children. Both blocks are already used in practice, so no major breakthrough is expected.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 5 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria * Male children aged 1-5 years * ASA physical status I-II * Scheduled for elective hypospadias repair under general anesthesia * Parent or legal guardian provides written informed consent * Able to complete postoperative assessments through 24 hours after surgery Exclusion Criteria * Parent/guardian refusal of participation * Coagulopathy or current anticoagulant therapy * Infection at the intended injection site (sacral/caudal region) or systemic infection * Allergy/hypersensitivity to amide local anesthetics (e.g., bupivacaine) or study medications * Neurologic or spinal disorders or congenital sacral anomalies affecting block safety * Significant hepatic, renal, or cardiac disease * Any other condition that, in the investigator's judgment, contraindicates caudal block or sacral ESPB or could interfere with safe participation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tanta University Hospital
RECRUITINGTanta, El-Gharbia Govenorate, 31527, Egypt
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