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

NCT06843070 | Active Not Recruiting

• 1 other identifier: Study Pedsac
• Study Type: observational
• 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

  Postoperative pain intensity will be assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) Scale. The FLACC Scale ranges from 0 to 10, with higher scores indicating greater pain intensity and therefore a worse outcome. Pain assessments will be performed upon admission to the post-anesthesia care unit and at 30-minute intervals during the post-anesthesia care unit stay, followed by assessments at postoperative hours 1, 2, 4, and 6 or until hospital discharge, whichever occurs first.

  From admission to the post-anesthesia care unit through postoperative hour 6.

Secondary Outcomes (1)

• SECONDARY OUTCOME

  Postoperative hour 6.

Study Arms (2)

Group P (Penile Block)

Patients who underwent Dorsal Penile Block after circumcision surgery

Procedure: PENILE BLOCK ARM

Group S (Sacral ESP Block)

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)
• Sampling Method: Probability Sample

Study Population

The study population consists of pediatric patients aged 7 to 12 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled for elective circumcision surgery under general anesthesia. All participants are required to be able to communicate pain perception reliably. Written informed consent will be obtained from parents or legal guardians prior to enrollment.

You may qualify if:

• Age 7 to 12 years.
• American Society of Anesthesiologists (ASA) Physical Status I or II.
• Scheduled to undergo elective circumcision under general anesthesia.
• Ability to communicate pain using the study pain assessment tools.
• Written informed consent obtained from a parent or legal guardian.

You may not qualify if:

• Refusal or inability of the parent/legal guardian or participant (when appropriate) to provide informed consent or assent.
• American Society of Anesthesiologists (ASA) Physical Status III or higher.
• Emergency surgery.
• History of significant hematologic, cardiovascular, hepatic, or renal disease.
• Current anticoagulant therapy.
• Known hypersensitivity or allergy to local anesthetic agents.
• Previous penile surgery.
• Any condition that, in the investigator's judgment, would interfere with study participation or outcome assessment.

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Yasin Tire

Konya, Meram, 42140, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• 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: July 15, 2026
• Study Completion (Estimated): August 25, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

TU (1)