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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Analgesia
• Intervention / Treatment: Procedure: PENILE BLOCK ARM; Procedure: SACRAL ESP BLOCK ARM

Detailed Description

Although it is not known exactly where it was first performed, there is evidence that the Egyptians performed circumcision in 2300 BC. While circumcision is performed for health reasons in some societies, it is a traditional, religious and cultural practice in some. In our clinic, circumcision cases are performed with anesthesia monitoring and premedication with midazolam (0.1 mg/kg) followed by penile block, which is our clinical practice, by experienced pediatric surgeons who perform the surgical procedure without the use of ultrasound. In addition to penile block in standard practice, general anesthesia is applied to patients with sevoflurane, ketamine, fentanyl and propofol, depending on the patient's age and weight, depending on the need for intraoperative anesthesia and analgesia. Postoperative pain after surgeries on the penis is a problem that directly affects postoperative recovery in young patients because the surgical procedure itself is often minor (treatment of phimosis, circumcision), whereas the pain produced is both severe and long-lasting.

The need for analgesia is a topic that always occupies anesthesia practice and maintains its relevance. It is vital to ensure early mobilization and discharge of patients. Many side effects, including somnolence, vomiting and respiratory depression, call into question the use of opioids in pediatrics.

Today, the use of ultrasound-guided nerve block has resulted in a revolutionary change in the field of regional anesthesia in pediatrics. Many truncal blocks are used with a high success rate in both upper and lower abdominal surgeries and have become standard in terms of patient safety.

Sacral ESP block, especially applied in children, has become an increasingly important technique due to its advantages such as applicability, ease of anatomical approach, distance to the medulla spinalis and surgical site, and low risk of infection. In addition, studies have shown that it is quite effective in postoperative pain.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yasin Tire; Phone Number: +905055367970; Email: dryasintire@hotmail.com

Study Locations

• Turkey
  • Meram
    • Konya, Meram, Turkey, 42140
      • Recruiting
      • Yasin Tire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Inclusion criteria of the patients: Age between 7-12 years, ASA Physical Status 1 and 2, circumcision surgery, general anesthesia, planned hospital stay of at least 24 hours.

Exclusion Criteria:

• Exclusion criteria were defined as patients whose family or personal consent could not be obtained for the study, Asa 3 and above cases, patients in the study age group who will undergo emergency surgery, patients with serious hematopoietic system, cardiovascular, liver or kidney disease, patients receiving anticoagulation therapy, patients with sensitivity to regional anesthetic agents and patients who have previously undergone penile surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group P (Penile Block); Patients who underwent Dorsal Penile Block after circumcision surgery	Procedure: PENILE BLOCK ARM; P arm: Patients who underwent Dorsal Penile Block after circumcision surgery
Active Comparator: Group S (Sacral ESP Block); Patients who underwent Sacral Erector Spinae Plane Block after circumcision surgery	Procedure: SACRAL ESP BLOCK ARM; S arm: Patients who underwent Sacral Erector Spinae Plane Block after circumcision surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
SECONDARY OUTCOME	As a secondary outcome variable, a simple pain scale was explained to parents to fill in the rating sheet as a measure of satisfaction with postoperative pain (0 = no pain/child calm; 1 = minimal pain/child irritable; 2 = mild pain/child consolable; and 3 = severe pain/child inconsolable).	postoperative '' before the discharge''

Collaborators and Investigators

• Sponsor: Konya City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Estimated): December 15, 2025
• Study Completion (Estimated): December 25, 2025

Study Registration Dates

• First Submitted: February 9, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): February 24, 2025

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Sacral Erector Spinae Plane Block; Pediatric Regional Anesthesia; Postoperative Analgesia in Circumcision
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: Study Pedsac

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No