Actively Recruiting
Prospective Comparison of Sacral Erector Spinae Plane Block and Caudal Epidural Block for Postoperative Analgesia in Pediatric Hypospadias Surgery
Led by TC Erciyes University · Updated on 2026-06-02
60
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hypospadias is a common congenital urogenital condition in children that often requires surgical correction during early childhood. Effective pain relief after surgery is important to improve comfort, reduce stress, and prevent complications. This study compares two methods of pain control, sacral erector spinae plane (ESP) block and caudal epidural block, in young male patients undergoing hypospadias repair to find which provides better postoperative analgesia. Participants aged 6 months to 7 years will receive either an ultrasound-guided sacral ESP block or a caudal epidural block under general anesthesia before surgery. Both blocks use 0.25% bupivacaine at a dose of 0.5 mL/kg. The sacral ESP block involves an in-plane needle technique guided by ultrasound over the sacral region, while the caudal epidural block is performed using anatomical landmarks to access the caudal epidural space. Pain levels will be measured using the FLACC scale at several times within 24 hours after surgery. Researchers will also track total pain medication use, time until first additional pain relief is needed, and any complications related to the blocks such as motor weakness, nausea, or bleeding. The study aims to assess and compare the effectiveness and safety of these two regional anesthesia techniques during the postoperative period.
CONDITIONS
Brief Title
Comparison of Sacral Erector Spinae Block and Caudal Epidural Block for Postoperative Analgesia in Pediatric Hypospadias Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged between 6 months to 7 years
- Scheduled for hypospadias repair surgery
- ASA physical status I or II
- No known allergy to local anesthetic agents
- No contraindications to peripheral nerve blocks
- Written informed consent obtained from parents or legal guardians
You will not qualify if you...
- Known congenital coagulopathy
- Known allergy to local anesthetic agents
- Severe systemic disease (ASA III-IV)
- Severe organ failure
- Neurological disorders
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 plus 24 hours post-surgery
Participants receive either a sacral erector spinae plane block or a caudal epidural block under general anesthesia prior to hypospadias surgery to manage postoperative pain.
1 visit (in-person) on surgery day and pain assessments at 30 minutes, 1, 4, 12, and 24 hours after surgery
Trial Site Locations
Total: 1 location
1
Erciyes University Faculty of Medicine Hospital
Kayseri, Turkey (Türkiye)
Actively Recruiting
Research Team
Ö
ÖZLEM ÖZ GERGİN, Principal Investigator
R
RABİA BÜŞRA SATICI, Study Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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