Elective Circumcision SurgeryPhase 4SACRAL ESPNCT07097844
A Comparison of the Efficacy of Sacral Erector Spinae Plane Block and Penile Block in Circumcision Surgery
A Phase 4 study testing 0.8 mL/kg of 0.25% bupivacaine in people with Elective Circumcision Surgery, run by Siirt Training and Research Hospital.
Trial summary
Effective perioperative analgesia is crucial for reducing hospital stay in pediatric surgical patients. Opioid-based analgesia, although effective, may lead to respiratory depression in the postoperative period. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Elective Circumcision Surgery
- What is being tested?
- 0.8 mL/kg of 0.25% bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 1 Feb 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I pediatric patients aged 2-7 years
- Scheduled for elective circumcision
- Informed consent obtained from parents/legal guardians
Who cannot join
- ASA score other than I
- Age <2 or >7 years
- Known allergy to local anesthetics
- Refusal to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Effective perioperative analgesia is crucial for reducing hospital stay in pediatric surgical patients. Opioid-based analgesia, although effective, may lead to respiratory depression in the postoperative period. Therefore, alternative regional anesthesia techniques such as penile block and sacral ESPB are increasingly preferred.
Sacral ESPB provides both somatic and visceral analgesia by blocking the dorsal and ventral rami of the spinal nerves. It has the potential to block the pudendal nerve and achieve bilateral effect with a single midline injection. However, comparative data between sacral ESPB and penile block in circumcision surgeries is limited.
Read the detailed description
Effective perioperative analgesia is crucial for reducing hospital stay in pediatric surgical patients. Opioid-based analgesia, although effective, may lead to respiratory depression in the postoperative period. Therefore, alternative regional anesthesia techniques such as penile block and sacral ESPB are increasingly preferred.
Sacral ESPB provides both somatic and visceral analgesia by blocking the dorsal and ventral rami of the spinal nerves. It has the potential to block the pudendal nerve and achieve bilateral effect with a single midline injection. However, comparative data between sacral ESPB and penile block in circumcision surgeries is limited.
In this prospective, double-blind, randomized controlled trial, 62 children aged 2 to 7 years undergoing elective circumcision at the Department of Pediatric Surgery of Diyarbakır Gazi Yaşargil Training and Research Hospital will be randomly assigned to two groups:
Group I will receive sacral ESPB using 0.8 mL/kg of 0.25% bupivacaine
Group II will receive a penile block using the same dosage and concentration.
Primary outcomes include intraoperative opioid use and postoperative rescue analgesic consumption within 24 hours. Secondary outcome includes time to discharge. Hemodynamic parameters and FLACC scores will be monitored at defined intervals.
- Conditions
- Elective Circumcision Surgery
- Being tested
- 0.8 mL/kg of 0.25% bupivacaine
- Keywords
- Sacral ESPB, Penile Block, Pediatric Regional Anesthesia, Circumcision, FLACC Score, Opioid Consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.8 mL/kg of 0.25% bupivacaineDrug
0.8 mL/kg of 0.25% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group I - Sacral ESPB | Active comparator | Type: Procedure
Name: Sacral Erector Spinae Plane Block
Description: Ultrasound-guided sacral ESPB using 0.8 mL/kg of 0.25% bupivacaine Receives: Drug: 0.8 mL/kg of 0.25% bupivacaine |
| Group II - Penile Block | Active comparator | Type: Procedure
Name: Penile Block
penile block using 0.8 mL/kg of 0.25% bupivacaine Receives: Drug: 0.8 mL/kg of 0.25% bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLACC Pain Score
Postoperative pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale at 0, 15, 30, 45, 60, 90 minutes, and 2, 4, 6, 8, 10, 12, 18, and 24 hours after surgery. A FLACC score ≥4 will be treated with rescue analgesia.
Measured: From arrival in the recovery room until 24 hours postoperatively
Secondary outcomes (1)
Total Perioperative Opioid and Rescue Analgesic Consumption
Measured as total intraoperative fentanyl usage and postoperative administration of paracetamol and ibuprofen.
Measured: Up to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start15 Aug 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Circumcision SurgeryStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siirt Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ali kendal oğuz, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097844
- Sponsor's protocol ID
- SAĞLIK BİLİMLERİ ÜNİVERSİTESİ
- Acronym
- SACRAL ESP
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing is currently under consideration. A final decision will be made after study completion and ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Efficacy of Sacral Erector Spinae Plane Block and Penile Block in Circumcision Surgery
- ClinicalTrials.gov ID
- NCT07097844
- Acronym / sponsor ID
- SACRAL ESP / SAĞLIK BİLİMLERİ ÜNİVERSİTESİ
- Conditions
- Elective Circumcision Surgery
- Keywords
- Sacral ESPB, Penile Block, Pediatric Regional Anesthesia, Circumcision, FLACC Score, Opioid Consumption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Siirt Training and Research HospitalOther government
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 31 Jul 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.
Effective perioperative analgesia is crucial for reducing hospital stay in pediatric surgical patients. Opioid-based analgesia, although effective, may lead to respiratory depression in the postoperative period. Therefore, alternative regional anesthesia techniques such as penile block and sacral ESPB are increasingly preferred.
Sacral ESPB provides both somatic and visceral analgesia by blocking the dorsal and ventral rami of the spinal nerves. It has the potential to block the pudendal nerve and achieve bilateral effect with a single midline injection. However, comparative data between sacral ESPB and penile block in circumcision surgeries is limited.
Detailed description
Effective perioperative analgesia is crucial for reducing hospital stay in pediatric surgical patients. Opioid-based analgesia, although effective, may lead to respiratory depression in the postoperative period. Therefore, alternative regional anesthesia techniques such as penile block and sacral ESPB are increasingly preferred.
Sacral ESPB provides both somatic and visceral analgesia by blocking the dorsal and ventral rami of the spinal nerves. It has the potential to block the pudendal nerve and achieve bilateral effect with a single midline injection. However, comparative data between sacral ESPB and penile block in circumcision surgeries is limited.
In this prospective, double-blind, randomized controlled trial, 62 children aged 2 to 7 years undergoing elective circumcision at the Department of Pediatric Surgery of Diyarbakır Gazi Yaşargil Training and Research Hospital will be randomly assigned to two groups:
Group I will receive sacral ESPB using 0.8 mL/kg of 0.25% bupivacaine
Group II will receive a penile block using the same dosage and concentration.
Primary outcomes include intraoperative opioid use and postoperative rescue analgesic consumption within 24 hours. Secondary outcome includes time to discharge. Hemodynamic parameters and FLACC scores will be monitored at defined intervals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I - Sacral ESPB | Active comparator | Drug: 0.8 mL/kg of 0.25% bupivacaineType: Procedure Name: Sacral Erector Spinae Plane Block Description: Ultrasound-guided sacral ESPB using 0.8 mL/kg of 0.25% bupivacaine |
| Group II - Penile Block | Active comparator | Drug: 0.8 mL/kg of 0.25% bupivacaineType: Procedure Name: Penile Block penile block using 0.8 mL/kg of 0.25% bupivacaine |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I pediatric patients aged 2-7 years
- Scheduled for elective circumcision
- Informed consent obtained from parents/legal guardians
Key exclusion criteria (4 listed)
- ASA score other than I
- Age <2 or >7 years
- Known allergy to local anesthetics
- Refusal to participate
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 |
|---|---|---|
| 0.8 mL/kg of 0.25% bupivacaine0.8 mL/kg of 0.25% bupivacaine | Drug | Group I - Sacral ESPB, Group II - Penile Block |
Primary outcome
FLACC Pain Score
Time frame: From arrival in the recovery room until 24 hours postoperatively
Postoperative pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale at 0, 15, 30, 45, 60, 90 minutes, and 2, 4, 6, 8, 10, 12, 18, and 24 hours after surgery. A FLACC score ≥4 will be treated with rescue analgesia.
1 secondary outcome
Total Perioperative Opioid and Rescue Analgesic Consumption
Time frame: Up to 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: Undecided. Data sharing is currently under consideration. A final decision will be made after study completion and ethical approval.
Related trials for Elective Circumcision Surgery
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Posthectomy in Pediatric Elective Surgery : a Comparison of Perioperative Analgesia Using Echo-guided Penile Block and Pudendal Block With neurostimuLation Technique
Postoperative Care, Analgesia Assessment
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.8 mL/kg of 0.25% bupivacaine in people with Elective Circumcision Surgery, run by Siirt Training and Research Hospital.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ali K oğuz, specialist doctor in anestesio (+905324683045, alikendal.oguz@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLACC Pain Score (time frame: From arrival in the recovery room until 24 hours postoperatively). 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 31 Jul 2025.