Postoperative AnalgesiaNCT06843070
Comparison of the Effects of Sacral Erector Spinae Plane Block and Dorsal Penile Block on Postoperative Pain in Circumcision Procedures
An observational study of Postoperative Analgesia, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- PENILE BLOCK ARM and SACRAL ESP BLOCK ARM
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2025to 3 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Postoperative Analgesia
- Being tested
- PENILE BLOCK ARM, SACRAL ESP BLOCK ARM
- Keywords
- Pediatric Regional Anesthesia, Sacral Erector Spinae Plane Block, Postoperative Analgesia in Circumcision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENILE BLOCK ARMProcedure or surgery
P arm: Patients who underwent Dorsal Penile Block after circumcision surgery
SACRAL ESP BLOCK ARMProcedure or surgery
S arm: Patients who underwent Sacral Erector Spinae Plane Block after circumcision surgery
| Study group | Role | What they receive |
|---|---|---|
| Group P (Penile Block) | Patients who underwent Dorsal Penile Block after circumcision surgery Receives: Procedure: PENILE BLOCK ARM | |
| Group S (Sacral ESP Block) | Patients who underwent Sacral Erector Spinae Plane Block after circumcision surgery Receives: Procedure: SACRAL ESP BLOCK ARM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Postoperative hour 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start25 Feb 2025
- Primary completion15 Aug 2026
- Study completion3 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Tire, MD, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843070
- Sponsor's protocol ID
- Study Pedsac
- Status last verified
- Oct 2026
- First submitted
- 9 Feb 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Sacral Erector Spinae Plane Block and Dorsal Penile Block on Postoperative Pain in Circumcision Operations
- ClinicalTrials.gov ID
- NCT06843070
- Acronym / sponsor ID
- Study Pedsac
- Conditions
- Postoperative Analgesia
- Keywords
- Pediatric Regional Anesthesia, Sacral Erector Spinae Plane Block, Postoperative Analgesia in Circumcision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 3 Oct 2026 (actual)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P (Penile Block) | – | Procedure: PENILE BLOCK ARMPatients who underwent Dorsal Penile Block after circumcision surgery |
| Group S (Sacral ESP Block) | – | Procedure: SACRAL ESP BLOCK ARMPatients who underwent Sacral Erector Spinae Plane Block after circumcision surgery |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PENILE BLOCK ARMP arm: Patients who underwent Dorsal Penile Block after circumcision surgery | Procedure or surgery | Group P (Penile Block) |
| SACRAL ESP BLOCK ARMS arm: Patients who underwent Sacral Erector Spinae Plane Block after circumcision surgery | Procedure or surgery | Group S (Sacral ESP Block) |
Primary outcome
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.
1 secondary outcome
SECONDARY OUTCOME
Time frame: Postoperative hour 6.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Analgesia, run by Konya City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRIMARY OUTCOME (time frame: From admission to the post-anesthesia care unit through postoperative hour 6.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.