CClinicalTrials.gg
CompletedNCT06843070Updated Oct 6, 2026

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

An observational study in Postoperative Analgesia, sponsored by Konya City Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Konya City Hospital · Observational

Updated Oct 6, 2026Now CompletedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
7 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Postoperative Analgesia

Keywords

  • Pediatric Regional Anesthesia
  • Sacral Erector Spinae Plane Block
  • Postoperative Analgesia in Circumcision
03

In context

Lead sponsor

Konya City Hospital is the lead sponsor of 76 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Eligibility criteria

**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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedurePENILE BLOCK ARM

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

  • ProcedureSACRAL ESP BLOCK ARM

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

06

What researchers measure

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.

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

Secondary outcomes

  1. SECONDARY OUTCOME

    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.

    Time frame: Postoperative hour 6.

07

Study locations

1 site
  • Yasin Tire
    Konya, Meram 42140, Turkey (Türkiye)
08

Updates

1 registry update since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Oct 6, 2026
Study completion
Aug 25, 2026→Oct 3, 2026 (actual)
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Active, not recruiting→Completed
    Study completion Aug 25, 2026→Oct 3, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06843070
Lead sponsor
Konya City Hospital
Responsible party
Yasin Tire, MD (Anesthesiology and Reanimation, Konya City Hospital) — Principal investigator
First posted
Feb 24, 2025
Start date
Feb 25, 2025
Primary completion
Aug 15, 2026
Completion
Oct 3, 2026
Last update
Oct 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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