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Clinical Trials in Turkey / NCT07321717
Starting soon Not applicable

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

NCT07321717 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-01-01
Last updated
2026-01-07

Condition(s) studied

Sacral Erector Spinae Plane BlockPediatric Regional AnesthesiaRegional Anaesthesia

Investigational drug(s) / intervention(s)

Sacral Erector Spinae Plane BlockPenile Nerve Block (PNB)

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.

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.

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.

Eligibility

Sex
ALL
Min age
1 Year
Max age
12 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty Bakırköy Istanbul

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07321717 on ClinicalTrials.gov ↗ ← All trials in Turkey