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Not Yet RecruitingNCT07097844

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

Status
Not Yet Recruiting
Phase
Phase 4
Study type
Interventional
Enrollment
62 (estimated)
Sponsor
Siirt Training and Research Hospital · Other Government
Sex
All
Age
2 Years – 7 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUG0.8 mL/kg of 0.25% bupivacaine0.8 mL/kg of 0.25% bupivacaine

Timeline

Start date
2025-08-15
Primary completion
2026-01-01
Completion
2026-02-01
First posted
2025-07-31
Last updated
2025-07-31

Source: ClinicalTrials.gov record NCT07097844. Inclusion in this directory is not an endorsement.