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

NCT07099560 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-09-09

No results posted yet for this study

Summary

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.

Conditions

  • Hypospadias
  • Caudal Block
  • Erector Spinae Plane Block
  • Pain, Postoperative

Interventions

PROCEDURE

Ultrasound-guided sacral erector spinae plane block (sESPB)

After 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.

PROCEDURE

Ultrasound-guided caudal epidural block

After 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.

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Principal Investigators

  • Ghada MA Elfekey, MBBCH · Faculty of Medicine, Tanta University, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07099560 on ClinicalTrials.gov