Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT07099560
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
1 Year
Maximum Age:
5 Years
Study:
NCT07099560
Study Brief:
Protocol Section:
NCT07099560