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

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07097844
Acronym
SACRAL ESP
Enrollment
62
Registered
2025-07-31
Start date
2025-08-15
Completion date
2026-02-01
Last updated
2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elective Circumcision Surgery

Keywords

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

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.

Detailed description

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. In this prospective, double-blind, randomized controlled trial, 62 children aged 2 to 7 years undergoing elective circumcision at the Department of Pediatric Surgery of Diyarbakır Gazi Yaşargil Training and Research Hospital will be randomly assigned to two groups: Group I will receive sacral ESPB using 0.8 mL/kg of 0.25% bupivacaine Group II will receive a penile block using the same dosage and concentration. Primary outcomes include intraoperative opioid use and postoperative rescue analgesic consumption within 24 hours. Secondary outcome includes time to discharge. Hemodynamic parameters and FLACC scores will be monitored at defined intervals.

Interventions

DRUG0.8 mL/kg of 0.25% bupivacaine

0.8 mL/kg of 0.25% bupivacaine

Sponsors

Siirt Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
FLACC Pain ScoreFrom arrival in the recovery room until 24 hours postoperativelyPostoperative 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.

Secondary

MeasureTime frameDescription
Total Perioperative Opioid and Rescue Analgesic ConsumptionUp to 24 hours postoperativelyMeasured as total intraoperative fentanyl usage and postoperative administration of paracetamol and ibuprofen.

Contacts

Primary Contactali K oğuz, specialist doctor in anestesio
alikendal.oguz@sbu.edu.tr+905324683045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026