Comparison of Sacral Erector Spinae Block and Caudal Epidural Block for Postoperative Analgesia in Pediatric Hypospadias Surgery

NCT07619651 | Recruiting

• 1 other identifier: 2025/519
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypospadias; Postoperative Pain

Keywords

Sacral Erector Spinae Plane Block; Caudal Epidural Block; Hypospadias Surgery; Postoperative Analgesia; Pediatric Urology

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Score Assessed by FLACC Scale

  Postoperative pain intensity will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale in pediatric patients undergoing hypospadias repair surgery. FLACC scores will be recorded at 30 minutes, and at 1, 4, 12, and 24 hours after surgery.

  Within the first 24 hours after surgery

Secondary Outcomes (3)

• Time to First Rescue Analgesia

  Within the first 24 hours after surgery

• Total Postoperative Analgesic Consumption

  Within the first 24 hours after surgery

• Block-Related Complications

  Within the first 24 hours after surgery

Study Arms (2)

Sacral ESP Block Group

EXPERIMENTAL

Patients receiving ultrasound-guided sacral erector spinae plane block for postoperative analgesia

Procedure: Sacral ESP Block

Caudal Epidural Block Group

ACTIVE COMPARATOR

Patients receiving caudal epidural block for postoperative analgesia

Procedure: Caudal Epidural Block

Interventions

Sacral ESP Block PROCEDURE

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.

Sacral ESP Block Group

Caudal Epidural Block PROCEDURE

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.

Caudal Epidural Block Group

Eligibility Criteria

• Age: 6 Months - 7 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• No contraindications to peripheral nerve blocks
• Written informed consent obtained from parents or legal guardians

You may not qualify if:

• Known congenital coagulopathy
• Known allergy to local anesthetic agents
• Severe systemic disease (ASA III-IV)
• Severe organ failure
• Neurological disorders

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Faculty of Medicine Hospital

Kayseri, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Tulgar S, Senturk O, Thomas DT, Deveci U, Ozer Z. A new technique for sensory blockage of posterior branches of sacral nerves: Ultrasound guided sacral erector spinae plane block. J Clin Anesth. 2019 Nov;57:129-130. doi: 10.1016/j.jclinane.2019.04.014. Epub 2019 Apr 15. No abstract available.

  PMID: 30999197 BACKGROUND

• Sancak Demirci NB, Kesici S, Oba S, Turk HS, Cinar AS, Demir M. Comparison of analgesic efficacy of sacral erector spinae plane block and caudal block in pediatric patients undergoing hypospadias repair surgery. J Pediatr Urol. 2025 Aug;21(4):885-893. doi: 10.1016/j.jpurol.2025.03.010. Epub 2025 Mar 20.

  PMID: 40180872 BACKGROUND

• Kaya C, Dost B, Tulgar S. Sacral Erector Spinae Plane Block Provides Surgical Anesthesia in Ambulatory Anorectal Surgery: Two Case Reports. Cureus. 2021 Jan 9;13(1):e12598. doi: 10.7759/cureus.12598.

  PMID: 33585088 BACKGROUND

• Bansal T, Yadav N, Singhal S, Kadian Y, Lal J, Jain M. Evaluation of USG-guided novel sacral erector spinae block for postoperative analgesia in pediatric patients undergoing hypospadias repair: A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2024 Apr-Jun;40(2):330-335. doi: 10.4103/joacp.joacp_418_22. Epub 2023 Jul 29.

  PMID: 38919450 BACKGROUND

MeSH Terms

Conditions

Hypospadias; Pain, Postoperative

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

ÖZLEM ÖZ GERGİN, Principal Investigator

CONTACT

0905332466396; oozgergin@erciyes.edu.tr

RABİA BÜŞRA SATICI, Study Coordinator

CONTACT

0905548846343; rabiaoztoprak@erciyes.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be allocated to one of two parallel groups to receive either sacral erector spinae plane block or caudal epidural block according to the study protocol.

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: June 2, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

TU (1)