Sacral Erector Spinae Plane Block Versus Penile Block For Analgesia In Pediatric Circumcision
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-12
SponsorIstanbul University - Cerrahpasa
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age under 1 year or over 12 years
Undergoing circumcision combined with other surgical procedures
Presence of neurological deficits
History of bleeding diathesis
Trial design
Design model
Parallel
Treatments tested in this trial
Sacral Erector Spinae Plane Block
Procedure/SurgeryParticipants 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)
Procedure/SurgeryParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Penile Nerve Block (PNB) groupActive comparator 1 intervention
Group B: Sacral Erector Spinae Plane Block (SESPB) groupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
0-24 hours after circumcision surgerySecondary outcomes
1
Total Analgesic Consumption in 24 Hours
Total amount of analgesics (intravenous and oral) administered within the first 24 hours after surgery will be recorded.
Time frame
0-24 hours postoperatively2
Intraoperative Analgesic Consumption
Total dose of remifentanil administered intraoperatively will be recorded and compared between the SESPB and PNB groups.
Time frame
During surgery3
Time to First Analgesic Requirement
Time from the end of surgery to the first need for rescue analgesia will be measured.
Time frame
0-24 hours postoperativelySponsors and contacts
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Source ClinicalTrials.gov
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