Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery

Tanta University

Status: Enrolling

Conditions: Caudal Block; Erector Spinae Plane Block; Pain, Postoperative; Hypospadias

Treatments: Procedure: Ultrasound-guided caudal epidural block; Procedure: Ultrasound-guided sacral erector spinae plane block (sESPB)

Study type: Interventional

Funder types: Other

Identifiers

NCT07099560

36264MS869/3/25

Details and patient eligibility

About

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. The primary outcome is pain over the first 24 hours, assessed using the FLACC scale at prespecified time points. Secondary outcomes include total opioid consumption, time to first rescue analgesia, postoperative nausea and vomiting, parent/guardian satisfaction, hemodynamic trends, and predefined adverse effects (e.g., motor weakness, urinary retention, respiratory depression, hematoma, infection at injection site). Perioperative care is standardized; rescue pethidine is administered when FLACC ≥4. The trial evaluates whether sESPB provides superior or comparable analgesia with fewer adverse effects than caudal block.

Full description

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. The primary outcome is pain over the first 24 hours, assessed using the FLACC scale at prespecified time points. Secondary outcomes include total opioid consumption, time to first rescue analgesia, postoperative nausea and vomiting, parent/guardian satisfaction, hemodynamic trends, and predefined adverse effects (e.g., motor weakness, urinary retention, respiratory depression, hematoma, infection at injection site). Perioperative care is standardized; rescue pethidine is administered when FLACC ≥4. The trial evaluates whether sESPB provides superior or comparable analgesia with fewer adverse effects than caudal block.

Enrollment: 70 estimated patients

Sex: Male

Ages: 1 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Arm A: Sacral Erector Spinae Plane Block (sESPB)

Experimental group

Description:

Participants receive bilateral ultrasound-guided sacral ESPB after induction of general anesthesia. Using a high-frequency linear probe, the needle is advanced to the sacral fascial plane near the median sacral crest; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL/kg (maximum total volume 20 mL) is injected. Standardized perioperative care; rescue analgesia (pethidine 0.5 mg/kg) if FLACC ≥4.

Treatment:

Procedure: Ultrasound-guided sacral erector spinae plane block (sESPB)

Arm B - Active Comparator: Caudal Epidural Block

Experimental group

Description:

Participants receive ultrasound-guided caudal epidural block after induction of general anesthesia. Needle introduced via the sacral hiatus under ultrasound; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL/kg (maximum total volume 20 mL) is injected. Standardized perioperative care; rescue pethidine if FLACC ≥4.

Treatment:

Procedure: Ultrasound-guided caudal epidural block