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

NCT07321717 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-07

No results posted yet for this study

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

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

Interventions

PROCEDURE

Sacral Erector Spinae Plane Block

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.

PROCEDURE

Penile Nerve Block (PNB)

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.

Sponsors & Collaborators

  • Istanbul University - Cerrahpasa

    lead OTHER

Principal Investigators

  • Munevver Kayhan · Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

  • Pinar Kendigelen · Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

  • Ayse Cigdem Tutuncu, Professor Doctor · Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

  • Ali Ekber Hakalmaz, Lecturer Doctor · Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-03-20
Completion
2026-04-10

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07321717 on ClinicalTrials.gov