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Clinical Trials in Turkey / NCT07619651
Recruiting Not applicable

Comparison of Sacral ESP Block and Caudal Block in Pediatric Hypospadias Surgery

NCT07619651 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-01-05
Last updated
2026-06-25

Condition(s) studied

HypospadiasPostoperative Pain

Investigational drug(s) / intervention(s)

Sacral ESP BlockCaudal Epidural Block

Sacral ESP Block: Sacral 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: Caudal 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.

Study summary

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

Sex
MALE
Min age
6 Months
Max age
7 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male patients aged between 6 months to 7 years 2. Scheduled for hypospadias repair surgery 3. ASA physical status I-II 4. No known allergy to local anesthetic agents 5. No contraindications to peripheral nerve blocks 6. Written informed consent obtained from parents or legal guardians Exclusion Criteria: 1. Known congenital coagulopathy 2. Known allergy to local anesthetic agents 3. Severe systemic disease (ASA III-IV) 4. Severe organ failure 5. Neurological disorders

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Erciyes University Faculty of Medicine Hospital Kayseri Turkey (Türkiye) Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07619651 on ClinicalTrials.gov ↗ ← All trials in Turkey