Comparison of Sacral ESP Block and Caudal Block in Pediatric Hypospadias Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age6-7
SponsorTC Erciyes University
About this trial
Hypospadias surgery in pediatric patients requires effective postoperative analgesia to ensure patient comfort and reduce perioperative stress. Caudal epidural block is widely used for analgesia in pediatric urological procedures; however, alternative regional techniques such as the sacral erector spinae plane (ESP) block have recently gained attention.
This prospective comparative study aims to compare the analgesic efficacy of sacral ESP block and caudal epidural block in pediatric patients undergoing hypospadias surgery. Participants will be allocated to receive either sacral ESP block or caudal epidural block according to the study protocol.
The primary outcome will be postoperative pain scores within the first 24 hours after surgery. Secondary outcomes will include total analgesic consumption, time to first rescue analgesia, and block-related complications.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male patients aged between 6 months to 7 years
Scheduled for hypospadias repair surgery
ASA physical status I-II
No known allergy to local anesthetic agents
Disqualifiers
Known congenital coagulopathy
Known allergy to local anesthetic agents
Severe systemic disease (ASA III-IV)
Severe organ failure
Trial design
Design model
Parallel
Treatments tested in this trial
Sacral ESP Block
Procedure/SurgerySacral erector spinae plane block will be performed under ultrasound guidance in pediatric patients under general anesthesia. A linear ultrasound probe will be placed in the longitudinally over the sacral region to identify the sacral median crest and erector spinae muscle. Using an in-plane technique, a block needle will be advanced in a cranial-to-caudal direction, and after negative aspiration, 0.25% bupivacaine at a dose of 0.5 mL/kg will be injected beneath the erector spinae muscle at the level of the sacral vertebra. The injection will be performed incrementally with intermittent aspiration to avoid intravascular injection.
Caudal Epidural Block
Procedure/SurgeryCaudal epidural block will be performed in pediatric patients under general anesthesia in the lateral decubitus position. The sacrococcygeal membrane will be identified using anatomical landmarks, and a needle will be inserted into the caudal epidural space. After negative aspiration, 0.25% bupivacaine at a dose of 0.5 mL/kg will be administered slowly. Intermittent aspiration will be performed during injection to minimize the risk of intravascular or intrathecal injection.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Sacral ESP Block GroupExperimental treatment 1 intervention
Group B: Caudal Epidural Block GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative Pain Score Assessed by FLACC Scale
Postoperative pain intensity will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale in pediatric patients undergoing hypospadias repair surgery. The FLACC scale consists of five behavioral categories (Face, Legs, Activity, Cry, Consolability), each scored from 0 to 2 points, resulting in a total score ranging from 0 to 10. Higher scores indicate greater pain intensity. FLACC scores will be recorded at 30 minutes, and at 1, 4, 12, and 24 hours after surgery. Rescue analgesia will be administered when the FLACC score is 4 or greater.
Time frame
Within the first 24 hours after surgerySecondary outcomes
1
Time to First Rescue Analgesia
Time from the end of surgery to the first administration of rescue analgesic medication will be recorded.
Time frame
Within the first 24 hours after surgery2
Total Postoperative Analgesic Consumption
Total amount of analgesic medications required within the first 24 hours after surgery will be recorded.
Time frame
Within the first 24 hours after surgery3
Block-Related Complications
Block-related complications including motor weakness, nausea and vomiting, hypotension, bradycardia, pruritus, intravascular injection, and bleeding will be assessed.
Time frame
Within the first 24 hours after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov