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NCT Number: NCT07097844

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

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.

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Key information

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.8 mL/kg of 0.25% bupivacaine

Drug

0.8 mL/kg of 0.25% bupivacaine

Primary outcomes

  1. FLACC Pain Score

    Time frame: From arrival in the recovery room until 24 hours postoperatively

    Postoperative 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 outcomes

  1. Total Perioperative Opioid and Rescue Analgesic Consumption

    Time frame: Up to 24 hours postoperatively

    Measured as total intraoperative fentanyl usage and postoperative administration of paracetamol and ibuprofen.

Study contacts

Contact information is provided by the study sponsor or research team.

ali K oğuz, specialist doctor in anestesio

CONTACT

[email protected]

+905324683045

Sponsors and collaborators

Lead sponsor

Siirt Training and Research Hospital

Other Gov

Registry information

Acronym: SACRAL ESP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.