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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age1-5
SponsorTanta University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ultrasound-guided sacral erector spinae plane block (sESPB)
  • Ultrasound-guided caudal epidural block

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators