Sacral Erector Spinae Plane Block Versus Penile Block For Analgesia In Pediatric Circumcision

NCT07321717 | Not Yet Recruiting

• 1 other identifier: ctf-sakral sünnet-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Circumcision is one of the most frequently performed surgical procedures in childhood and is associated with significant postoperative pain. This randomized controlled trial (RCT) aims to compare the analgesic effectiveness of sacral erector spinae plane block (sacral ESPB) and penile nerve block (PNB) in children undergoing circumcision surgery. The primary outcome is postoperative pain, assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale at predefined time intervals within the first 24 hours after surgery. Secondary outcomes include intraoperative analgesic consumption, time to first postoperative analgesic requirement, perioperative hemodynamic changes. The results of this study are expected to provide evidence for selecting the optimal regional analgesic technique for pediatric circumcision surgery.

Conditions

Regional Anaesthesia; Sacral Erector Spinae Plane Block; Pediatric Regional Anesthesia

Keywords

pediatric regional anesthesia; sacral ESP

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Scores within 24 Hours

  Postoperative pain will be assessed using the FLACC scale (Face, Legs, Activity, Cry, Consolability) at multiple time points (0, 1, 2, 4, 8, 12, 16, and 24 hours postoperatively). Scores range from 0-10, where higher scores indicate more severe pain and lower scores indicate less pain. The primary outcome is the comparison of pain levels between the Sacral Erector Spinae Plane Block (SESPB) group and the Penile Nerve Block (PNB) group during the first 24 hours after surgery.

  0-24 hours after circumcision surgery

Secondary Outcomes (3)

• Total Analgesic Consumption in 24 Hours

  0-24 hours postoperatively

• Intraoperative Analgesic Consumption

  During surgery

• Time to First Analgesic Requirement

  0-24 hours postoperatively

Study Arms (2)

Penile Nerve Block (PNB) group

ACTIVE COMPARATOR

Participants in this group will receive the standard penile nerve block prior to surgery. The block is performed by subcutaneous infiltration of 0.5 ml/kg of 0.25% bupivacaine around the ventral penoscrotal junction and base of the penis. This is the standard clinical practice group used for comparison.

Procedure: Penile Nerve Block (PNB)

Sacral Erector Spinae Plane Block (SESPB) group

EXPERIMENTAL

Participants in this group will receive a sacral ESPB before circumcision surgery. The block is performed with 0.5 ml/kg of 0.25% bupivacaine under ultrasound guidance using an in-plane, craniocaudal approach while the child is in the prone position. This is the investigational intervention being studied for analgesic effectiveness and safety.

Procedure: Sacral Erector Spinae Plane Block

Interventions

Sacral Erector Spinae Plane Block PROCEDURE

Participants will receive a sacral ESPB prior to circumcision surgery. 0.5 ml/kg of 0.25% bupivacaine is injected under ultrasound guidance using an in-plane, craniocaudal approach while the child is in the prone position. This is the investigational procedure being studied for analgesic effectiveness and safety.

Sacral Erector Spinae Plane Block (SESPB) group

Penile Nerve Block (PNB) PROCEDURE

Participants will receive the standard penile nerve block prior to surgery. 0.5 ml/kg of 0.25% bupivacaine is infiltrated subcutaneously around the ventral penoscrotal junction and base of the penis. This serves as the standard comparator.

Penile Nerve Block (PNB) group

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age between 1 and 12 years
• Scheduled for circumcision surgery
• Classified as American Society of Anesthesiologists (ASA) physical status I-II
• Written informed consent obtained from both the participant (when appropriate) and their parents or legal guardians

You may not qualify if:

• Age under 1 year or over 12 years
• Undergoing circumcision combined with other surgical procedures
• Presence of neurological deficits
• History of bleeding diathesis
• Allergy to local anesthetic (LA) drugs
• Redness or infection at the injection site
• Presence of congenital sacral anomalies
• Mental retardation
• Psychiatric disorders or kidney disease
• Refusal to participate in the study

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

Bakırköy, Istanbul, 34153, Turkey (Türkiye)

Location

Study Officials

• Munevver Kayhan

  Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

  PRINCIPAL INVESTIGATOR

• Pinar Kendigelen

  Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

  STUDY CHAIR

• Ayse Cigdem Tutuncu, Professor Doctor

  Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

  STUDY CHAIR

• Ali Ekber Hakalmaz, Lecturer Doctor

  Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

  STUDY CHAIR

Central Study Contacts

Munevver Kayhan, Lecturer Doctor

CONTACT

02124143000; munevver.kayhan@iuc.edu.tr

Pinar Kendigelen, Professor Doctor

CONTACT

02124143000; pinarken@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study is double-blind to compare the analgesic effectiveness and safety of Penile Nerve Block (PNB) and Sacral Erector Spinae Plane Block (sacral ESPB) in pediatric circumcision. Participants (children) and outcome assessors are unaware of group assignment to minimize bias. Postoperative pain and outcomes are measured using the FLACC scale (Face, Legs, Activity, Cry, Consolability), where higher scores indicate more severe pain and lower scores less pain. Only the anesthesiologists performing the blocks know the assigned intervention for safety and correct technique; they do not collect postoperative data. Blinding ensures objective assessment of pain, analgesic consumption, hemodynamic changes, and complications during the perioperative and postoperative period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Participants will be randomly assigned to one of two independent groups: the Penile Nerve Block (PNB) group or the Sacral Erector Spinae Plane Block (sacral ESPB) group. Each participant will receive only the assigned intervention and will be followed throughout the perioperative and postoperative period. The parallel design allows comparison of analgesic effectiveness, safety, and postoperative outcomes between the two independent groups

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: January 1, 2026
• Primary Completion: March 20, 2026
• Study Completion: April 10, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)