Sacral Erector Spinae Plane BlockNCT07321717
Sacral Erector Spinae Plane Block Versus Penile Block For Analgesia In Pediatric Circumcision
A study testing Sacral Erector Spinae Plane Block and Penile Nerve Block (PNB) in people with Sacral Erector Spinae Plane Block and Pediatric Regional Anesthesia, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Circumcision is one of the most frequently performed surgical procedures in childhood and is associated with significant postoperative pain. This randomized controlled trial (RCT) aims to compare the analgesic effectiveness of sacral erector spinae plane block (sacral ESPB) and penile nerve block (PNB) in children… Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Sacral Erector Spinae Plane Block, Pediatric Regional Anesthesia, Regional Anaesthesia
- What is being tested?
- Sacral Erector Spinae Plane Block and Penile Nerve Block (PNB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 10 Apr 2026
- Phase
- Interventional
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 1 and 12 years
- Scheduled for circumcision surgery
- Classified as American Society of Anesthesiologists (ASA) physical status I-II
- Written informed consent obtained from both the participant (when appropriate) and their parents or legal guardians
Who cannot join
- Age under 1 year or over 12 years
- Undergoing circumcision combined with other surgical procedures
- Presence of neurological deficits
- History of bleeding diathesis
- Allergy to local anesthetic (LA) drugs
- Redness or infection at the injection site
Show all 10Show fewer
- Presence of congenital sacral anomalies
- Mental retardation
- Psychiatric disorders or kidney disease
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
Bakırköy, Istanbul, 34153
Munevver Kayhan, Lecturer Doctor, 02124143000, munevver.kayhan@iuc.edu.tr
About this study
Official title: A Randomized Controlled Trial Comparing The Analgesic Effectiveness Of Sacral Erector Spinae Plane Block And Penile Block In Children Undergoing Circumcision Surgery
Circumcision is one of the most frequently performed surgical procedures in childhood and is associated with significant postoperative pain. This randomized controlled trial (RCT) aims to compare the analgesic effectiveness of sacral erector spinae plane block (sacral ESPB) and penile nerve block (PNB) in children undergoing circumcision surgery. The primary outcome is postoperative pain, assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale at predefined time intervals within the first 24 hours after surgery. Secondary outcomes include intraoperative analgesic consumption, time to first postoperative analgesic requirement, perioperative hemodynamic changes. The results of this study are expected to provide evidence for selecting the optimal regional analgesic technique for pediatric circumcision surgery.
Read the detailed description
Circumcision is one of the most commonly performed surgical procedures in childhood and is associated with significant postoperative pain. Inadequate analgesia in pediatric patients may lead to adverse hemodynamic, hormonal, metabolic, and immunological responses, as well as increased agitation and discomfort. Therefore, a multimodal analgesia (MMA) approach is recommended to prevent the onset of pain and provide effective perioperative analgesia. Regional anesthesia (RA) techniques offer safe, effective, and hemodynamically stable analgesia in pediatric patients. Penile nerve block (PNB) is a commonly used RA technique for circumcision, performed by subcutaneous infiltration of local anesthetic around the glans penis and penoscrotal junction. More recently, the sacral erector spinae plane block (sacral ESPB) has been introduced as an alternative RA method, providing wide analgesic coverage by affecting the pudendal nerve and its branches. Sacral ESPB has been successfully applied in pediatric urogenital and anorectal surgeries, demonstrating effective postoperative analgesia.
This randomized controlled trial (RCT) aims to compare the analgesic effectiveness of sacral ESPB and PNB in children aged 1-12 years with American Society of Anesthesiologists (ASA) physical status I-II undergoing circumcision surgery. Participants will be randomly allocated using a closed-envelope method to one of two groups. The PNB group will receive 0.5 mL/kg of 0.25% bupivacaine via circumferential subcutaneous injection along the penoscrotal line. The sacral ESPB group will receive 0.5 mL/kg of 0.25% bupivacaine under ultrasound (USG) guidance using an in-plane, cranio-caudal technique. All procedures will be performed by pediatric anesthesia faculty experienced in RA. Premedication will include intravenous (IV) midazolam 0.05 mg/kg and ketamine 0.5 mg/kg. General anesthesia (GA) will be induced with IV propofol 2-3 mg/kg, fentanyl 1 µg/kg, and rocuronium 0.6 mg/kg, followed by endotracheal intubation and maintenance with sevoflurane 1 minimum alveolar concentration (MAC). Intraoperative monitoring will include electrocardiography (ECG), peripheral oxygen saturation (SpO₂), and non-invasive blood pressure (NIBP). Hemodynamic changes exceeding 20% from baseline will be treated with remifentanil infusion.
Blinding (Körleme): This study will be conducted using a double-blind design. The patients and the investigators responsible for postoperative pain assessment and data collection will be unaware of group allocation. Only the anesthesiologists performing the blocks will know which intervention (PNB or sacral ESPB) is administered to ensure patient safety. This approach minimizes bias and ensures objective evaluation of outcomes.
Postoperative pain will be assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale, which ranges from 0 to 10 points. A higher FLACC score indicates more severe pain, while a lower score indicates less pain. Analgesic administration will follow a standardized protocol: FLACC ≤3 indicates sufficient analgesia; FLACC 4-6 will be treated with IV paracetamol 10 mg/kg; FLACC ≥7 will be treated with IV fentanyl 0.5 µg/kg in the recovery unit. On the ward, oral paracetamol 10 mg/kg or ibuprofen 10 mg/kg will be administered according to FLACC scores. Phone follow-up at 16 and 24 hours will monitor pain scores and rescue analgesic consumption.
The primary outcome is postoperative pain within the first 24 hours as measured by FLACC scores. Secondary outcomes include intraoperative analgesic consumption, time to first postoperative analgesic requirement, perioperative hemodynamic changes, time to first urination, parental satisfaction, and postoperative adverse events such as nausea, vomiting, or block-related complications.
This study aims to determine the optimal regional analgesic technique for pediatric circumcision surgery by comparing the efficacy, safety, and satisfaction outcomes of sacral ESPB and PNB.
- Being tested
- Sacral Erector Spinae Plane Block, Penile Nerve Block (PNB)
- Keywords
- pediatric regional anesthesia, sacral ESP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral Erector Spinae Plane BlockProcedure or surgery
Participants will receive a sacral ESPB prior to circumcision surgery. 0.5 ml/kg of 0.25% bupivacaine is injected under ultrasound guidance using an in-plane, craniocaudal approach while the child is in the prone position. This is the investigational procedure being studied for analgesic effectiveness and safety.
Penile Nerve Block (PNB)Procedure or surgery
Participants will receive the standard penile nerve block prior to surgery. 0.5 ml/kg of 0.25% bupivacaine is infiltrated subcutaneously around the ventral penoscrotal junction and base of the penis. This serves as the standard comparator.
| Study group | Role | What they receive |
|---|---|---|
| Penile Nerve Block (PNB) group | Active comparator | Participants in this group will receive the standard penile nerve block prior to surgery. The block is performed by subcutaneous infiltration of 0.5 ml/kg of 0.25% bupivacaine around the ventral penoscrotal junction and base of the penis. This is the standard clinical practice group used for comparison. Receives: Procedure: Penile Nerve Block (PNB) |
| Sacral Erector Spinae Plane Block (SESPB) group | Experimental | Participants in this group will receive a sacral ESPB before circumcision surgery. The block is performed with 0.5 ml/kg of 0.25% bupivacaine under ultrasound guidance using an in-plane, craniocaudal approach while the child is in the prone position. This is the investigational intervention being studied for analgesic effectiveness and safety. Receives: Procedure: Sacral Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Scores within 24 Hours
Postoperative pain will be assessed using the FLACC scale (Face, Legs, Activity, Cry, Consolability) at multiple time points (0, 1, 2, 4, 8, 12, 16, and 24 hours postoperatively). Scores range from 0-10, where higher scores indicate more severe pain and lower scores indicate less pain. The primary outcome is the comparison of pain levels between the Sacral Erector Spinae Plane Block (SESPB) group and the Penile Nerve Block (PNB) group during the first 24 hours after surgery.
Measured: 0-24 hours after circumcision surgery
Secondary outcomes (3)
Total Analgesic Consumption in 24 Hours
Total amount of analgesics (intravenous and oral) administered within the first 24 hours after surgery will be recorded.
Measured: 0-24 hours postoperatively
Intraoperative Analgesic Consumption
Total dose of remifentanil administered intraoperatively will be recorded and compared between the SESPB and PNB groups.
Measured: During surgery
Time to First Analgesic Requirement
Time from the end of surgery to the first need for rescue analgesia will be measured.
Measured: 0-24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion20 Mar 2026 (estimated)
- Study completion10 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacral Erector Spinae Plane BlockStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two independent groups: the Penile Nerve Block (PNB) group or the Sacral Erector Spinae Plane Block (sacral ESPB) group. Each participant will receive only the assigned intervention and will be followed throughout the perioperative and postoperative period. The parallel design allows comparison of analgesic effectiveness, safety, and postoperative outcomes between the two independent groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Münevver Kayhan, Istanbul University - Cerrahpasa
- Investigators
- Munevver Kayhan, Principal investigator, Istanbul University-Cerrahpasa, Cerrahpasa Medicine of FacultyPinar Kendigelen, Study chair, Istanbul University-Cerrahpasa, Cerrahpasa Medicine of FacultyAyse Cigdem Tutuncu, Professor Doctor, Study chair, Istanbul University-Cerrahpasa, Cerrahpasa Medicine of FacultyAli Ekber Hakalmaz, Lecturer Doctor, Study chair, Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321717
- Sponsor's protocol ID
- ctf-sakral sünnet-03
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing The Analgesic Effectiveness Of Sacral Erector Spinae Plane Block And Penile Block In Children Undergoing Circumcision Surgery
- ClinicalTrials.gov ID
- NCT07321717
- Acronym / sponsor ID
- ctf-sakral sünnet-03
- Keywords
- pediatric regional anesthesia, sacral ESP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 10 Apr 2026 (estimated)
- First posted
- 7 Jan 2026 (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.
Circumcision is one of the most frequently performed surgical procedures in childhood and is associated with significant postoperative pain. This randomized controlled trial (RCT) aims to compare the analgesic effectiveness of sacral erector spinae plane block (sacral ESPB) and penile nerve block (PNB) in children undergoing circumcision surgery. The primary outcome is postoperative pain, assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale at predefined time intervals within the first 24 hours after surgery. Secondary outcomes include intraoperative analgesic consumption, time to first postoperative analgesic requirement, perioperative hemodynamic changes. The results of this study are expected to provide evidence for selecting the optimal regional analgesic technique for pediatric circumcision surgery.
Detailed description
Circumcision is one of the most commonly performed surgical procedures in childhood and is associated with significant postoperative pain. Inadequate analgesia in pediatric patients may lead to adverse hemodynamic, hormonal, metabolic, and immunological responses, as well as increased agitation and discomfort. Therefore, a multimodal analgesia (MMA) approach is recommended to prevent the onset of pain and provide effective perioperative analgesia. Regional anesthesia (RA) techniques offer safe, effective, and hemodynamically stable analgesia in pediatric patients. Penile nerve block (PNB) is a commonly used RA technique for circumcision, performed by subcutaneous infiltration of local anesthetic around the glans penis and penoscrotal junction. More recently, the sacral erector spinae plane block (sacral ESPB) has been introduced as an alternative RA method, providing wide analgesic coverage by affecting the pudendal nerve and its branches. Sacral ESPB has been successfully applied in pediatric urogenital and anorectal surgeries, demonstrating effective postoperative analgesia.
This randomized controlled trial (RCT) aims to compare the analgesic effectiveness of sacral ESPB and PNB in children aged 1-12 years with American Society of Anesthesiologists (ASA) physical status I-II undergoing circumcision surgery. Participants will be randomly allocated using a closed-envelope method to one of two groups. The PNB group will receive 0.5 mL/kg of 0.25% bupivacaine via circumferential subcutaneous injection along the penoscrotal line. The sacral ESPB group will receive 0.5 mL/kg of 0.25% bupivacaine under ultrasound (USG) guidance using an in-plane, cranio-caudal technique. All procedures will be performed by pediatric anesthesia faculty experienced in RA. Premedication will include intravenous (IV) midazolam 0.05 mg/kg and ketamine 0.5 mg/kg. General anesthesia (GA) will be induced with IV propofol 2-3 mg/kg, fentanyl 1 µg/kg, and rocuronium 0.6 mg/kg, followed by endotracheal intubation and maintenance with sevoflurane 1 minimum alveolar concentration (MAC). Intraoperative monitoring will include electrocardiography (ECG), peripheral oxygen saturation (SpO₂), and non-invasive blood pressure (NIBP). Hemodynamic changes exceeding 20% from baseline will be treated with remifentanil infusion.
Blinding (Körleme): This study will be conducted using a double-blind design. The patients and the investigators responsible for postoperative pain assessment and data collection will be unaware of group allocation. Only the anesthesiologists performing the blocks will know which intervention (PNB or sacral ESPB) is administered to ensure patient safety. This approach minimizes bias and ensures objective evaluation of outcomes.
Postoperative pain will be assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale, which ranges from 0 to 10 points. A higher FLACC score indicates more severe pain, while a lower score indicates less pain. Analgesic administration will follow a standardized protocol: FLACC ≤3 indicates sufficient analgesia; FLACC 4-6 will be treated with IV paracetamol 10 mg/kg; FLACC ≥7 will be treated with IV fentanyl 0.5 µg/kg in the recovery unit. On the ward, oral paracetamol 10 mg/kg or ibuprofen 10 mg/kg will be administered according to FLACC scores. Phone follow-up at 16 and 24 hours will monitor pain scores and rescue analgesic consumption.
The primary outcome is postoperative pain within the first 24 hours as measured by FLACC scores. Secondary outcomes include intraoperative analgesic consumption, time to first postoperative analgesic requirement, perioperative hemodynamic changes, time to first urination, parental satisfaction, and postoperative adverse events such as nausea, vomiting, or block-related complications.
This study aims to determine the optimal regional analgesic technique for pediatric circumcision surgery by comparing the efficacy, safety, and satisfaction outcomes of sacral ESPB and PNB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two independent groups: the Penile Nerve Block (PNB) group or the Sacral Erector Spinae Plane Block (sacral ESPB) group. Each participant will receive only the assigned intervention and will be followed throughout the perioperative and postoperative period. The parallel design allows comparison of analgesic effectiveness, safety, and postoperative outcomes between the two independent groups
| Arm | Type | Receives |
|---|---|---|
| Penile Nerve Block (PNB) group | Active comparator | Procedure: Penile Nerve Block (PNB)Participants in this group will receive the standard penile nerve block prior to surgery. The block is performed by subcutaneous infiltration of 0.5 ml/kg of 0.25% bupivacaine around the ventral penoscrotal junction and base of the penis. This is the standard clinical practice group used for comparison. |
| Sacral Erector Spinae Plane Block (SESPB) group | Experimental | Procedure: Sacral Erector Spinae Plane BlockParticipants in this group will receive a sacral ESPB before circumcision surgery. The block is performed with 0.5 ml/kg of 0.25% bupivacaine under ultrasound guidance using an in-plane, craniocaudal approach while the child is in the prone position. This is the investigational intervention being studied for analgesic effectiveness and safety. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age between 1 and 12 years
- Scheduled for circumcision surgery
- Classified as American Society of Anesthesiologists (ASA) physical status I-II
- Written informed consent obtained from both the participant (when appropriate) and their parents or legal guardians
Key exclusion criteria (10 listed)
- Age under 1 year or over 12 years
- Undergoing circumcision combined with other surgical procedures
- Presence of neurological deficits
- History of bleeding diathesis
- Allergy to local anesthetic (LA) drugs
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 |
|---|---|---|
| Sacral Erector Spinae Plane BlockParticipants will receive a sacral ESPB prior to circumcision surgery. 0.5 ml/kg of 0.25% bupivacaine is injected under ultrasound guidance using an in-plane, craniocaudal approach while the child is in the prone position. This is the investigational procedure being studied for analgesic effectiveness and safety. | Procedure or surgery | Sacral Erector Spinae Plane Block (SESPB) group |
| Penile Nerve Block (PNB)Participants will receive the standard penile nerve block prior to surgery. 0.5 ml/kg of 0.25% bupivacaine is infiltrated subcutaneously around the ventral penoscrotal junction and base of the penis. This serves as the standard comparator. | Procedure or surgery | Penile Nerve Block (PNB) group |
Primary outcome
Postoperative Pain Scores within 24 Hours
Time frame: 0-24 hours after circumcision surgery
Postoperative pain will be assessed using the FLACC scale (Face, Legs, Activity, Cry, Consolability) at multiple time points (0, 1, 2, 4, 8, 12, 16, and 24 hours postoperatively). Scores range from 0-10, where higher scores indicate more severe pain and lower scores indicate less pain. The primary outcome is the comparison of pain levels between the Sacral Erector Spinae Plane Block (SESPB) group and the Penile Nerve Block (PNB) group during the first 24 hours after surgery.
3 secondary outcomes
Total Analgesic Consumption in 24 Hours
Time frame: 0-24 hours postoperatively
Intraoperative Analgesic Consumption
Time frame: During surgery
Time to First Analgesic Requirement
Time frame: 0-24 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 7 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Munevver Kayhan principal investigator
Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
Pinar Kendigelen study chair
Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
Ayse Cigdem Tutuncu, Professor Doctor study chair
Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral Erector Spinae Plane Block and Penile Nerve Block (PNB) in people with Sacral Erector Spinae Plane Block and Pediatric Regional Anesthesia, run by Istanbul University - Cerrahpasa 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 4 inclusion and 10 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 7 Jan 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?
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 Munevver Kayhan, Lecturer Doctor (02124143000, munevver.kayhan@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Scores within 24 Hours (time frame: 0-24 hours after circumcision surgery). 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 7 Jan 2026.