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.
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
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
Parallel
Ultrasound-guided sacral erector spinae plane block (sESPB)
Procedure/SurgeryAfter induction of general anesthesia, bilateral sESPB is performed under ultrasound guidance. Needle advanced to the sacral interfascial plane near the median sacral crest; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL/kg (max total 20 mL) is injected. Standardized perioperative care; rescue pethidine 0.5 mg/kg if FLACC ≥4.
Ultrasound-guided caudal epidural block
Procedure/SurgeryAfter induction of general anesthesia, caudal epidural injection via sacral hiatus under ultrasound guidance; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL/kg (max total 20 mL) is injected. Standardized perioperative care; rescue pethidine if FLACC ≥4.
FLACC pain score (0-10) during the first 24 hours after surgery
The FLACC scale (Face, Legs, Activity, Cry, Consolability) is a validated behavioral pain measure. Each category is scored 0-2; the total score ranges 0-10 with higher scores indicating more pain. Scores will be recorded at rest by a blinded outcomes assessor at the prespecified time points. Rescue analgesia is IV pethidine 0.5 mg/kg when FLACC ≥4. The primary analysis compares groups across time (mixed-effects model) and/or as the time-weighted mean over 0-24 h.
Total opioid consumption (pethidine), 0-24 h (mg/kg)
Cumulative dose of IV pethidine given as rescue analgesia when FLACC ≥4, from PACU arrival through 24 h post-op. Sum all doses per participant; no other opioids planned. Group summaries will be reported.
Time to first rescue analgesia requirement postoperatively
If FLACC pain score ≥ 4 I.V pethidine 0.5 mg/kg will be given as rescue analgesia.
Parent's satisfaction
Parent's Satisfaction Level were recorded on a numerical scale from 1 to 3 (not satisfied - neutral - satisfied).
Incidence of postoperative adverse events
Postoperative adverse events as nausea and vomiting, motor weakness, urinary retention, drowsiness, respiratory depression, hematoma or infection at the site of injection will be recorded.
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