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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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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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

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Elective Circumcision Surgery

Keywords

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Sacral ESPB Penile Block Pediatric Regional Anesthesia Circumcision FLACC Score Opioid Consumption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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

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0.8 mL/kg of 0.25% bupivacaine

0.8 mL/kg of 0.25% bupivacaine

Intervention Type DRUG

Eligibility Criteria

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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

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Siirt Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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ali kendal oğuz

specialist doctor in anestesiology and reanimation

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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ali K oğuz, specialist doctor in anestesio

Role: CONTACT

Phone: +905324683045

Email: [email protected]

Other Identifiers

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SAĞLIK BİLİMLERİ ÜNİVERSİTESİ

Identifier Type: -

Identifier Source: org_study_id