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

NCT ID: NCT06843070

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-25
• Study Completion Date: 2025-12-25

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.

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.

Conditions

Postoperative Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group P (Penile Block)

Patients who underwent Dorsal Penile Block after circumcision surgery

Group Type: ACTIVE_COMPARATOR

PENILE BLOCK ARM

Intervention Type: PROCEDURE

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

Group S (Sacral ESP Block)

Patients who underwent Sacral Erector Spinae Plane Block after circumcision surgery

Group Type: ACTIVE_COMPARATOR

SACRAL ESP BLOCK ARM

Intervention Type: PROCEDURE

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

Interventions

PENILE BLOCK ARM

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

Intervention Type: PROCEDURE

SACRAL ESP BLOCK ARM

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Konya City Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yasin Tire, MD

Anesthesiology and Reanimation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Yasin Tire

Konya, Meram, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Yasin Tire

Role: CONTACT

dryasintire@hotmail.com

+905055367970

Other Identifiers

Study Pedsac

Identifier Type: -

Identifier Source: org_study_id