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Compares treatment options for Hypospadias
Official title Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery
ClinicalTrials.gov ID: NCT07099560
What this study is testing
- What it's testing
- Randomized, parallel-group, assessor-blinded clinical trial at Tanta University Hospitals comparing ultrasound-guided sacral erector spinae plane block (sESPB) versus ultrasound-guided caudal epidural block for postoperative analgesia in male children (1-5 years) undergoing hypospadias repair. Seventy participants will be randomized 1:1 to receive sESPB or caudal block with 0.25% bupivacaine (0.5-1 mL/kg; maximum 20 mL) after induction of general anesthesia.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 5, men only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tanta, El-Gharbia Govenorate, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 1 year to 5 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tanta, El-Gharbia Govenorate, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.