RecruitingNot ApplicableNCT07099560

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

Comparison of Preemptive Analgesic Effect of Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery


Sponsor

Tanta University

Enrollment

70 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 1 YearMax Age: 5 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Ultrasound-guided caudal epidural block and a procedure called Ultrasound-guided sacral erector spinae plane block (sESPB) for people with caudal block, erector spinae plane block, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include men aged 1 Year to 5 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREUltrasound-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.

PROCEDUREUltrasound-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.


Locations(1)

Tanta University Hospital

Tanta, El-Gharbia Govenorate, Egypt

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07099560


Related Trials