Actively Recruiting
Comparison of Ultrasound-Guided Sacral Erector Spinae Plane Block Versus Caudal Epidural Block for Postoperative Pain Relief in Male Children Undergoing Hypospadias Surgery
Led by Tanta University · Updated on 2025-09-09
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates postoperative pain relief methods in male children aged 1 to 5 years undergoing hypospadias repair surgery. It compares two ultrasound-guided nerve block techniques: the sacral erector spinae plane block (sESPB) and the caudal epidural block. The study aims to determine if sESPB offers better or similar pain control with fewer side effects than the caudal block. Participants are randomly assigned to receive either the sESPB or caudal block after general anesthesia begins. Both groups receive 0.25% bupivacaine at a dose of 0.5 to 1 mL per kilogram, with a maximum total of 20 mL. The procedures are performed using ultrasound guidance, and standardized perioperative care is provided. Rescue pain medication (pethidine) is given if pain scores reach a certain level. During the 24 hours after surgery, pain is measured at several time points using the FLACC scale, a tool for assessing pain in young children. Researchers also monitor opioid use, time until first additional pain medicine, nausea, vomiting, parent satisfaction, vital signs, and any side effects such as motor weakness or infections. The study lasts through the first day after surgery to closely track recovery and safety.
CONDITIONS
Brief Title
Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Parent or guardian refuses participation
- Coagulopathy or current anticoagulant therapy
- Infection at the sacral or caudal injection site or systemic infection
- Allergy or hypersensitivity to amide local anesthetics like bupivacaine
- Neurologic or spinal disorders or congenital sacral anomalies affecting block safety
- Significant liver, kidney, or heart disease
- Any other condition judged to contraindicate caudal block or sacral ESPB or interfere with safe participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day
Participants receive either an ultrasound-guided sacral erector spinae plane block or an ultrasound-guided caudal epidural block after induction of general anesthesia during hypospadias surgery. Standardized perioperative care is provided, and rescue analgesia is given if needed based on pain assessment.
1 surgical visit (in-person)
Duration - 24 hours after surgery
Participants are monitored for pain relief and potential adverse effects during the first 24 hours after surgery. Pain is assessed at specified intervals, and opioid use and parent satisfaction are evaluated.
Multiple assessments during the first 24 hours post-surgery
Trial Site Locations
Total: 1 location
1
Tanta University Hospital
Tanta, El-Gharbia Govenorate, Egypt, 31527
Actively Recruiting
Research Team
G
Ghada MA Elfekey, MBBCH
M
Marwa A Eloraby, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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