A Comparison of the Efficacy of Sacral Erector Spinae Plane Block and Penile Block in Circumcision Surgery (SACRAL ESP)

Siirt Training and Research Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Elective Circumcision Surgery

Treatments: Drug: 0.8 mL/kg of 0.25% bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT07097844

SAĞLIK BİLİMLERİ ÜNİVERSİTESİ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: All

Ages: 2 to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Group I - Sacral ESPB

Active Comparator group

Description:

Type: Procedure Name: Sacral Erector Spinae Plane Block Description: Ultrasound-guided sacral ESPB using 0.8 mL/kg of 0.25% bupivacaine

Treatment:

Drug: 0.8 mL/kg of 0.25% bupivacaine

Group II - Penile Block

Active Comparator group

Description:

Type: Procedure Name: Penile Block penile block using 0.8 mL/kg of 0.25% bupivacaine

Treatment:

Drug: 0.8 mL/kg of 0.25% bupivacaine