Comparison of the Effects of Sacral Erector Spinae Plane Block and Dorsal Penile Block on Postoperative Pain in Circumcision Procedures

NCT06843070 | Recruiting

• 1 other identifier: Study Pedsac
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Egypt performed circumcision in 2300 BC, although its origin is unknown. Some societies use circumcision for health, whereas others do it for religious and cultural reasons . Our competent pediatric surgeons perform circumcisions without ultrasonography using midazolam (0.1 mg/kg) premedication and penile block. In addition to penile block, general anesthesia is given using sevoflurane, ketamine, fentanyl, and propofol, depending on age and weight, for intraoperative anesthesia and analgesia. Penis procedures are frequently simple (phimosis, circumcision), but the pain is significant and long-lasting, affecting young patients' postoperative recovery. The topic of analgesia remains relevant and important in anesthesia practice. Early patient mobilization and discharge are crucial. Pediatric opioid use is questioned due to adverse effects include somnolence, vomiting, and respiratory depression. The advent of ultrasound-guided nerve blocks has revolutionized regional anesthesia in pediatrics. Many upper and lower abdominal operations use truncal blocks with good success and patient safety. Since its applicability, ease of anatomical approach, distance to the medulla spinalis and surgical site, and minimal risk of infection, sacral ESP block has become a popular method for youngsters. Postoperative pain trials demonstrate it works well.

Conditions

Postoperative Analgesia

Keywords

Pediatric Regional Anesthesia; Sacral Erector Spinae Plane Block; Postoperative Analgesia in Circumcision

Outcome Measures

Primary Outcomes (1)

• PRIMARY OUTCOME

  The primary outcome variable of the study will be the FLACC pain score transferred to the pacu after surgery. Patients will be assessed for pain with the FLACC pain scale at 30-minute intervals throughout the pacu stay and at 0, 1, 2, 4 and 6 hours until discharge from the hospital.

  Postoperative ''0 hour, 1. hour, 2.hour, 4.hour, 6 hour

Secondary Outcomes (1)

• SECONDARY OUTCOME

  postoperative '' before the discharge''

Study Arms (2)

Group P (Penile Block)

ACTIVE COMPARATOR

Patients who underwent Dorsal Penile Block after circumcision surgery

Procedure: PENILE BLOCK ARM

Group S (Sacral ESP Block)

ACTIVE COMPARATOR

Patients who underwent Sacral Erector Spinae Plane Block after circumcision surgery

Procedure: SACRAL ESP BLOCK ARM

Interventions

PENILE BLOCK ARM PROCEDURE

P arm: Patients who underwent Dorsal Penile Block after circumcision surgery

Group P (Penile Block)

SACRAL ESP BLOCK ARM PROCEDURE

S arm: Patients who underwent Sacral Erector Spinae Plane Block after circumcision surgery

Group S (Sacral ESP Block)

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Yasin Tire

Konya, Meram, 42140, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Yasin Tire

CONTACT

+905055367970; dryasintire@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The single-blind design of this study keeps some participants unaware of their group designations to reduce bias. Evaluators: Clinicians collecting postoperative data and assessing pain will be blinded to patient group allocation. This eliminates subjective FLACC pain scoring and postoperative analgesia evaluation. A blinded observer will measure FLACC pain at 0, 1, 2, 4, and 6 hours postoperatively.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 24, 2025
• Study Start: February 25, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 25, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

TU (1)