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

NCT07097844 | Not Yet Recruiting Phase 4

• 1 other identifier: SAĞLIK BİLİMLERİ ÜNİVERSİTESİ
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Elective Circumcision Surgery

Keywords

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

Outcome Measures

Primary Outcomes (1)

• FLACC Pain Score

  Postoperative pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale at 0, 15, 30, 45, 60, 90 minutes, and 2, 4, 6, 8, 10, 12, 18, and 24 hours after surgery. A FLACC score ≥4 will be treated with rescue analgesia.

  From arrival in the recovery room until 24 hours postoperatively

Secondary Outcomes (1)

• Total Perioperative Opioid and Rescue Analgesic Consumption

  Up to 24 hours postoperatively

Study Arms (2)

Group I - Sacral ESPB

ACTIVE COMPARATOR

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

Drug: 0.8 mL/kg of 0.25% bupivacaine

Group II - Penile Block

ACTIVE COMPARATOR

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

Drug: 0.8 mL/kg of 0.25% bupivacaine

Interventions

0.8 mL/kg of 0.25% bupivacaine DRUG

0.8 mL/kg of 0.25% bupivacaine

Group I - Sacral ESPB; Group II - Penile Block

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA I pediatric patients aged 2-7 years
• Scheduled for elective circumcision
• Informed consent obtained from parents/legal guardians

You may not qualify if:

• ASA score other than I
• Age \<2 or \>7 years
• Known allergy to local anesthetics
• Refusal to participate

Sponsors & Collaborators

• Siirt Training and Research Hospital: lead

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

ali K oğuz, specialist doctor in anestesio

CONTACT

+905324683045; alikendal.oguz@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist doctor in anestesiology and reanimation

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: August 15, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07