Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06843070

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yasin Tire

Konya, Meram, 42140, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

**Inclusion Criteria:**

  • 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.

**Exclusion Criteria:**

  • 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.

Treatment and study plan

PENILE BLOCK ARM

Procedure

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

SACRAL ESP BLOCK ARM

Procedure

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

Primary outcomes

  1. PRIMARY OUTCOME

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

    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.

Secondary outcomes

  1. SECONDARY OUTCOME

    Time frame: Postoperative hour 6.

    Parents will assess their child's postoperative pain before hospital discharge using a 4-point Simple Pain Scale. Scores range from 0 to 3, where 0 indicates no pain or a calm child, 1 indicates minimal pain or an irritable child, 2 indicates mild pain or a consolable child, and 3 indicates severe pain or an inconsolable child. Higher scores indicate greater pain intensity and therefore a worse outcome.

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.