HypospadiasNCT07286786
Comparison of Analgesic Efficacy of Sacral Erector Spinae Plane Block and Caudal Epidural Block in Pediatric Patients Undergoing Hypospadias Surgery
An observational study of Hypospadias, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn about effects of block strategies (sacral erector spinae plane block - ESP, caudal block) on perioperative pain in pediatric patients undergoing hypospadias surgery. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Hypospadias
- What is being tested?
- Caudal Block Anesthesia and Erector Spinae Plane Block
- Type of treatment
- Surgery or procedure
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2025to 15 Sep 2025
- 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 1 year to 7 years
- All sexes
- Child
Study population: The study included children with ASA I-II, who will undergo hypospadias surgery under general anesthesia, between 1 and 7 years of age, who have no contraindications for block application, and whose legal guardians agreed to participate in the study.
Who may be able to join
- Children aged 1-7 years
- Classified as ASA physical status I-II
- Scheduled for primary hypospadias repair were enrolled
Who cannot join
- Infection at the injection site
- Coagulopathy
- Spinal anomalies
- Allergy to local anesthetics
- Parental refusal.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi
Istanbul, Şişli, 34384
About this study
The goal of this observational study is to learn about effects of block strategies (sacral erector spinae plane block - ESP, caudal block) on perioperative pain in pediatric patients undergoing hypospadias surgery. The main question it aims to answer is:
Is there a difference in analgesic efficacy between sacral erector spinae plane block and caudal block in pediatric patients undergoing hypospadias surgery? Eighty six pediatric patients (ages 1-7 years, ASA I-II) scheduled for hypospadias repair under general anesthesia were included in this prospective randomized study. Both blocks were performed using 0.25% bupivacaine, at doses of 0.5 mL/kg for our study. Pain was assessed using the FLACC scale at 1, 2, 4, 6, 12 and 24 hours postoperatively.
Read the detailed description
Postoperative pain management in pediatric urological surgery, particularly in hypospadias repair, is essential for reducing distress, minimizing analgesic requirements, and promoting early recovery. Caudal epidural block remains the gold standard for postoperative analgesia in this patient population due to its well-established safety and efficacy. However, its limitations-such as the risk of motor block, urinary retention, and unpredictable spread of local anesthetic-have encouraged the exploration of alternative regional techniques.
The sacral erector spinae plane (ESP) block, first described for thoracic and lumbar analgesia, has recently been applied in the sacral region as a novel approach for pediatric surgeries involving the perineum and genital area. The block is technically simpler, avoids the epidural space, and carries a low risk of complications. Nevertheless, data comparing its efficacy with the traditional caudal block in hypospadias surgery remain limited.
This study aimed to compare the analgesic efficacy and safety of sacral ESP block and caudal epidural block in children undergoing hypospadias repair surgery.
- Conditions
- Hypospadias
- Being tested
- Caudal Block Anesthesia, Erector Spinae Plane Block
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal Block AnesthesiaProcedure or surgery
Caudal block, with its simple application system, high success rate (98-100%), and ability to provide reliable analgesia, is a first-line block method for pain control compared to other options, including peripheral blocks. It provides analgesic effects in the dermatomal region between T10 and S5.
It is indicated for chronic back care in adults and for painful infraumbilical procedures such as pediatric circulation, hypospadias repair, circumcision, inguinal hernia repair, and anal atresia surgery.
Although it is sometimes used as the sole anesthesia method in pediatric surgery, it is generally used in conjunction with general anesthesia. Congenital or therapeutic coagulation disorders should be excluded before application. Contraindications for caudal block in children include local vascular involvement, hairline cysts, and congenital spinal anomalies.
Erector Spinae Plane BlockProcedure or surgery
In this block, a local anesthetic agent is injected into the fascial plane of the superficial and deep erector spinae muscle at the distal end of the transverse process of the vertebra. The aim is to block the dorsal and ventral rami of the spinal nerves. This block occurs through four different mechanisms: direct action on nerves in the fascial plane, diffusion into the paravertebral space, systemic absorption, and perforation on nerves in nearby compartments.
Because the erector spinae muscle extends along the vertebra, ESPB can be preferred for analgesia in the neck, chest, trunk, and lower and upper extremities. With a single-level block, the local anesthetic agent spreads approximately 3-6 vertebral levels in a cranio-caudal direction. This provides guidance on the level at which the block should be performed, depending on the surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group C (caudal block) | Group Receives: Procedure: Caudal Block Anesthesia | |
| Group S (sacral ESP block) | Cohort Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain status of patients in both groups will be evaluated with the FLACC score at postoperative 1, 2, 4, 6, 12 and 24 hours.
FLACC: Face, Leg, Activity, Cry, Consolability. The FLACC score is an observational pain assessment tool used primarily in pediatric patients who are unable to communicate verbally. It evaluates pain based on five behavioral categories: 'Face, Legs, Activity, Cry, and Consolability', each scored from 0 to 2, resulting in a total score ranging from 0 to 10. A score of 0 indicates no pain, while 1-3 reflects mild pain, 4-6 moderate pain, and 7-10 severe pain. Higher FLACC scores represent poorer pain control and greater patient discomfort, whereas lower scores suggest effective analgesia and adequate patient comfort. Elevated FLACC scores are clinically significant, as they are associated with increased stress responses, agitation, fluctuations in cardiopulmonary parameters, delayed mobilization, and prolonged recovery in pediatric patients.
Measured: It will be evaluated at 1, 2, 4, 6, 12 and 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 posted16 Dec 2025
- Study start18 Jan 2025
- Primary completion18 Aug 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypospadiasStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyye, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286786
- Sponsor's protocol ID
- CemilTasciogluDr.Kankal
- Status last verified
- Oct 2025
- First submitted
- 3 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
- Undecided
Publications
Kankal S, Bozdana M, Turan EI, Ciftci B, Ozen V. Comparison of sacral erector spinae plane block and caudal epidural block for postoperative analgesia in pediatric hypospadias surgery: a prospective observational study. Perioper Med (Lond). 2026 Jun 9. doi: 10.1186/s13741-026-00705-1. Online ahead of print.
PubMed 42265792
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
- Comparison of Analgesic Efficacy of Sacral Erector Spinae Plane Block and Caudal Epidural Block in Pediatric Patients Undergoing Hypospadias Surgery
- ClinicalTrials.gov ID
- NCT07286786
- Acronym / sponsor ID
- CemilTasciogluDr.Kankal
- Conditions
- Hypospadias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 18 Jan 2025 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 16 Dec 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.
The goal of this observational study is to learn about effects of block strategies (sacral erector spinae plane block - ESP, caudal block) on perioperative pain in pediatric patients undergoing hypospadias surgery. The main question it aims to answer is:
Is there a difference in analgesic efficacy between sacral erector spinae plane block and caudal block in pediatric patients undergoing hypospadias surgery? Eighty six pediatric patients (ages 1-7 years, ASA I-II) scheduled for hypospadias repair under general anesthesia were included in this prospective randomized study. Both blocks were performed using 0.25% bupivacaine, at doses of 0.5 mL/kg for our study. Pain was assessed using the FLACC scale at 1, 2, 4, 6, 12 and 24 hours postoperatively.
Detailed description
Postoperative pain management in pediatric urological surgery, particularly in hypospadias repair, is essential for reducing distress, minimizing analgesic requirements, and promoting early recovery. Caudal epidural block remains the gold standard for postoperative analgesia in this patient population due to its well-established safety and efficacy. However, its limitations-such as the risk of motor block, urinary retention, and unpredictable spread of local anesthetic-have encouraged the exploration of alternative regional techniques.
The sacral erector spinae plane (ESP) block, first described for thoracic and lumbar analgesia, has recently been applied in the sacral region as a novel approach for pediatric surgeries involving the perineum and genital area. The block is technically simpler, avoids the epidural space, and carries a low risk of complications. Nevertheless, data comparing its efficacy with the traditional caudal block in hypospadias surgery remain limited.
This study aimed to compare the analgesic efficacy and safety of sacral ESP block and caudal epidural block in children undergoing hypospadias repair surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C (caudal block) | – | Procedure: Caudal Block AnesthesiaGroup |
| Group S (sacral ESP block) | – | Procedure: Erector Spinae Plane BlockCohort |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Age groups
- Child
- Study population
- The study included children with ASA I-II, who will undergo hypospadias surgery under general anesthesia, between 1 and 7 years of age, who have no contraindications for block application, and whose legal guardians agreed to participate in the study.
Key inclusion criteria (3 listed)
- Children aged 1-7 years
- Classified as ASA physical status I-II
- Scheduled for primary hypospadias repair were enrolled
Key exclusion criteria (5 listed)
- Infection at the injection site
- Coagulopathy
- Spinal anomalies
- Allergy to local anesthetics
- Parental refusal.
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 |
|---|---|---|
| Caudal Block AnesthesiaCaudal block, with its simple application system, high success rate (98-100%), and ability to provide reliable analgesia, is a first-line block method for pain control compared to other options, including peripheral blocks. It provides analgesic effects in the dermatomal region between T10 and S5. It is indicated for chronic back care in adults and for painful infraumbilical procedures such as pediatric circulation, hypospadias repair, circumcision, inguinal hernia repair, and anal atresia surgery. Although it is sometimes used as the sole anesthesia method in pediatric surgery, it is generally used in conjunction with general anesthesia. Congenital or therapeutic coagulation disorders should be excluded before application. Contraindications for caudal block in children include local vascular involvement, hairline cysts, and congenital spinal anomalies. | Procedure or surgery | Group C (caudal block) |
| Erector Spinae Plane BlockIn this block, a local anesthetic agent is injected into the fascial plane of the superficial and deep erector spinae muscle at the distal end of the transverse process of the vertebra. The aim is to block the dorsal and ventral rami of the spinal nerves. This block occurs through four different mechanisms: direct action on nerves in the fascial plane, diffusion into the paravertebral space, systemic absorption, and perforation on nerves in nearby compartments. Because the erector spinae muscle extends along the vertebra, ESPB can be preferred for analgesia in the neck, chest, trunk, and lower and upper extremities. With a single-level block, the local anesthetic agent spreads approximately 3-6 vertebral levels in a cranio-caudal direction. This provides guidance on the level at which the block should be performed, depending on the surgical procedure. | Procedure or surgery | Group S (sacral ESP block) |
Primary outcome
The pain status of patients in both groups will be evaluated with the FLACC score at postoperative 1, 2, 4, 6, 12 and 24 hours.
Time frame: It will be evaluated at 1, 2, 4, 6, 12 and 24 hours postoperatively.
FLACC: Face, Leg, Activity, Cry, Consolability. The FLACC score is an observational pain assessment tool used primarily in pediatric patients who are unable to communicate verbally. It evaluates pain based on five behavioral categories: 'Face, Legs, Activity, Cry, and Consolability', each scored from 0 to 2, resulting in a total score ranging from 0 to 10. A score of 0 indicates no pain, while 1-3 reflects mild pain, 4-6 moderate pain, and 7-10 severe pain. Higher FLACC scores represent poorer pain control and greater patient discomfort, whereas lower scores suggest effective analgesia and adequate patient comfort. Elevated FLACC scores are clinically significant, as they are associated with increased stress responses, agitation, fluctuations in cardiopulmonary parameters, delayed mobilization, and prolonged recovery in pediatric patients.
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 7 Jan 2026.
- Derived from this study: PubMed 42265792Kankal S, Bozdana M, Turan EI, Ciftci B, Ozen V. Comparison of sacral erector spinae plane block and caudal epidural block for postoperative analgesia in pediatric hypospadias surgery: a prospective observational study. Perioper Med (Lond). 2026 Jun 9. doi: 10.1186/s13741-026-00705-1. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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 Hypospadias, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization 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 3 inclusion and 5 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 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?
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?
The pain status of patients in both groups will be evaluated with the FLACC score at postoperative 1, 2, 4, 6, 12 and 24 hours. (time frame: It will be evaluated at 1, 2, 4, 6, 12 and 24 hours postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07286786, which also lists 1 linked publication.
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.