A Comparison of the Efficacy of Sacral Erector Spinae Plane Block and Penile Block in Circumcision Surgery

NCT ID: NCT07097844

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2026-02-01

Brief Summary

Effective perioperative analgesia is crucial for reducing hospital stay in pediatric surgical patients. Opioid-based analgesia, although effective, may lead to respiratory depression in the postoperative period. Therefore, alternative regional anesthesia techniques such as penile block and sacral ESPB are increasingly preferred.

Sacral ESPB provides both somatic and visceral analgesia by blocking the dorsal and ventral rami of the spinal nerves. It has the potential to block the pudendal nerve and achieve bilateral effect with a single midline injection. However, comparative data between sacral ESPB and penile block in circumcision surgeries is limited.

Detailed Description

Effective perioperative analgesia is crucial for reducing hospital stay in pediatric surgical patients. Opioid-based analgesia, although effective, may lead to respiratory depression in the postoperative period. Therefore, alternative regional anesthesia techniques such as penile block and sacral ESPB are increasingly preferred.

Sacral ESPB provides both somatic and visceral analgesia by blocking the dorsal and ventral rami of the spinal nerves. It has the potential to block the pudendal nerve and achieve bilateral effect with a single midline injection. However, comparative data between sacral ESPB and penile block in circumcision surgeries is limited.

In this prospective, double-blind, randomized controlled trial, 62 children aged 2 to 7 years undergoing elective circumcision at the Department of Pediatric Surgery of Diyarbakır Gazi Yaşargil Training and Research Hospital will be randomly assigned to two groups:

Group I will receive sacral ESPB using 0.8 mL/kg of 0.25% bupivacaine

Group II will receive a penile block using the same dosage and concentration.

Primary outcomes include intraoperative opioid use and postoperative rescue analgesic consumption within 24 hours. Secondary outcome includes time to discharge. Hemodynamic parameters and FLACC scores will be monitored at defined intervals.

Conditions

Elective Circumcision Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group I - Sacral ESPB

Type: Procedure

Name: Sacral Erector Spinae Plane Block

Description: Ultrasound-guided sacral ESPB using 0.8 mL/kg of 0.25% bupivacaine

Group Type: ACTIVE_COMPARATOR

0.8 mL/kg of 0.25% bupivacaine

Intervention Type: DRUG

0.8 mL/kg of 0.25% bupivacaine

Group II - Penile Block

Type: Procedure

Name: Penile Block

penile block using 0.8 mL/kg of 0.25% bupivacaine

Group Type: ACTIVE_COMPARATOR

0.8 mL/kg of 0.25% bupivacaine

Intervention Type: DRUG

0.8 mL/kg of 0.25% bupivacaine

Interventions

0.8 mL/kg of 0.25% bupivacaine

0.8 mL/kg of 0.25% bupivacaine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

ASA I pediatric patients aged 2-7 years

Scheduled for elective circumcision

Informed consent obtained from parents/legal guardians

Exclusion Criteria

ASA score other than I

Age <2 or >7 years

Known allergy to local anesthetics

Refusal to participate

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Siirt Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

ali kendal oğuz

specialist doctor in anestesiology and reanimation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

ali K oğuz, specialist doctor in anestesio

Role: CONTACT

alikendal.oguz@sbu.edu.tr

+905324683045

Other Identifiers

SAĞLIK BİLİMLERİ ÜNİVERSİTESİ

Identifier Type: -

Identifier Source: org_study_id