HypospadiasNCT07619651
Comparison of Sacral ESP Block and Caudal Block in Pediatric Hypospadias Surgery
A study testing Sacral ESP Block and Caudal Epidural Block in people with Hypospadias and Postoperative Pain, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Hypospadias surgery in pediatric patients requires effective postoperative analgesia to ensure patient comfort and reduce perioperative stress. Caudal epidural block is widely used for analgesia in pediatric urological procedures; however, alternative regional techniques such as the sacral erector spinae plane (ESP)… Read more about this study
- Who is it for?
- Ages 6 months to 7 years, men only
- Conditions the study is for
- Hypospadias, Postoperative Pain
- What is being tested?
- Sacral ESP Block and Caudal Epidural Block
- 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
- 5 Jan 2026to 1 Nov 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 6 months to 7 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Male patients aged between 6 months to 7 years
- Scheduled for hypospadias repair surgery
- ASA physical status I-II
- No known allergy to local anesthetic agents
- No contraindications to peripheral nerve blocks
- Written informed consent obtained from parents or legal guardians
Who cannot join
- Known congenital coagulopathy
- Known allergy to local anesthetic agents
- Severe systemic disease (ASA III-IV)
- Severe organ failure
- Neurological disorders
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, 1 recruiting
- Recruiting
Erciyes University Faculty of Medicine Hospital
Kayseri
ÖZLEM ÖZ GERGİN, Principal Investigator, 0905332466396, oozgergin@erciyes.edu.tr
RABİA BÜŞRA SATICI, Study Coordinator, 0905548846343, rabiaoztoprak@erciyes.edu.tr
About this study
Official title: Prospective Comparison of Sacral Erector Spinae Plane Block and Caudal Epidural Block for Postoperative Analgesia in Pediatric Hypospadias Surgery
Hypospadias surgery in pediatric patients requires effective postoperative analgesia to ensure patient comfort and reduce perioperative stress. Caudal epidural block is widely used for analgesia in pediatric urological procedures; however, alternative regional techniques such as the sacral erector spinae plane (ESP) block have recently gained attention.
This prospective comparative study aims to compare the analgesic efficacy of sacral ESP block and caudal epidural block in pediatric patients undergoing hypospadias surgery. Participants will be allocated to receive either sacral ESP block or caudal epidural block according to the study protocol.
The primary outcome will be postoperative pain scores within the first 24 hours after surgery. Secondary outcomes will include total analgesic consumption, time to first rescue analgesia, and block-related complications.
Read the detailed description
Hypospadias is one of the most common congenital urogenital anomalies in pediatric patients and typically requires surgical correction in early childhood. Effective postoperative pain management is essential to improve patient comfort, reduce perioperative stress, and prevent complications. Inadequate pain control in pediatric surgical patients has been associated with increased morbidity, prolonged hospital stay, and delayed recovery.
Caudal epidural block is widely used for postoperative analgesia in pediatric urological surgery due to its ease of application and high success rate. However, it has limitations such as relatively short duration of analgesia and potential side effects including motor block, urinary retention, and lower extremity weakness. Therefore, alternative regional anesthesia techniques that may provide longer-lasting analgesia with fewer side effects are of increasing interest.
The erector spinae plane (ESP) block is a relatively novel regional anesthesia technique that provides both somatic and visceral analgesia and can be applied at different spinal levels. The sacral approach to ESP block has recently been described as a potential alternative for lower abdominal and urogenital surgeries. However, evidence regarding its effectiveness in pediatric hypospadias surgery remains limited.
This prospective comparative study aims to compare the analgesic efficacy, postoperative analgesic requirements, and block-related complications of sacral erector spinae plane block and caudal epidural block in pediatric patients undergoing hypospadias repair surgery.
Patients aged between 6 months and 7 years with ASA physical status I-II scheduled for hypospadias repair will be included. Participants will be allocated into either the sacral ESP block group or the caudal epidural block group according to the study protocol.
All patients will receive standardized general anesthesia and monitoring. Regional blocks will be performed under general anesthesia prior to surgery. In the sacral ESP block group, the block will be performed under ultrasound guidance using an in-plane technique, and 0.25% bupivacaine at a dose of 0.5 mL/kg will be administered. In the caudal epidural block group, the block will be performed using a standard technique with 0.25% bupivacaine at a dose of 0.5 mL/kg.
Postoperative pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale at 30 minutes, and at 1, 4, 12, and 24 hours after surgery. Total postoperative analgesic consumption, time to first rescue analgesia, and block-related complications (including motor weakness, nausea and vomiting, hypotension, bradycardia, pruritus, intravascular injection, and bleeding) will be recorded.
Statistical analysis will be performed using appropriate tests according to data distribution, with a significance level set at p < 0.05.
- Conditions
- Hypospadias, Postoperative Pain
- Being tested
- Sacral ESP Block, Caudal Epidural Block
- Keywords
- Sacral Erector Spinae Plane Block, Caudal Epidural Block, Hypospadias Surgery, Postoperative Analgesia, Pediatric Urology
- Medical subject headings
- Hypospadias, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral ESP BlockProcedure or surgery
Sacral erector spinae plane block will be performed under ultrasound guidance in pediatric patients under general anesthesia. A linear ultrasound probe will be placed in the longitudinally over the sacral region to identify the sacral median crest and erector spinae muscle. Using an in-plane technique, a block needle will be advanced in a cranial-to-caudal direction, and after negative aspiration, 0.25% bupivacaine at a dose of 0.5 mL/kg will be injected beneath the erector spinae muscle at the level of the sacral vertebra. The injection will be performed incrementally with intermittent aspiration to avoid intravascular injection.
Caudal Epidural BlockProcedure or surgery
Caudal epidural block will be performed in pediatric patients under general anesthesia in the lateral decubitus position. The sacrococcygeal membrane will be identified using anatomical landmarks, and a needle will be inserted into the caudal epidural space. After negative aspiration, 0.25% bupivacaine at a dose of 0.5 mL/kg will be administered slowly. Intermittent aspiration will be performed during injection to minimize the risk of intravascular or intrathecal injection.
| Study group | Role | What they receive |
|---|---|---|
| Sacral ESP Block Group | Experimental | Patients receiving ultrasound-guided sacral erector spinae plane block for postoperative analgesia Receives: Procedure: Sacral ESP Block |
| Caudal Epidural Block Group | Active comparator | Patients receiving caudal epidural block for postoperative analgesia Receives: Procedure: Caudal Epidural Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score Assessed by FLACC Scale
Postoperative pain intensity will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale in pediatric patients undergoing hypospadias repair surgery. The FLACC scale consists of five behavioral categories (Face, Legs, Activity, Cry, Consolability), each scored from 0 to 2 points, resulting in a total score ranging from 0 to 10. Higher scores indicate greater pain intensity. FLACC scores will be recorded at 30 minutes, and at 1, 4, 12, and 24 hours after surgery. Rescue analgesia will be administered when the FLACC score is 4 or greater.
Measured: Within the first 24 hours after surgery
Secondary outcomes (3)
Time to First Rescue Analgesia
Time from the end of surgery to the first administration of rescue analgesic medication will be recorded.
Measured: Within the first 24 hours after surgery
Total Postoperative Analgesic Consumption
Total amount of analgesic medications required within the first 24 hours after surgery will be recorded.
Measured: Within the first 24 hours after surgery
Block-Related Complications
Block-related complications including motor weakness, nausea and vomiting, hypotension, bradycardia, pruritus, intravascular injection, and bleeding will be assessed.
Measured: Within the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start5 Jan 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be allocated to one of two parallel groups to receive either sacral erector spinae plane block or caudal epidural block according to the study protocol.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem ÖZ GERGİN, TC Erciyes University
- Investigators
- ÖZLEM ÖZ GERGİN, Principal investigator, Erciyes University Faculty of MedicineRABİA BÜŞRA SATICI, Study director, Erciyes University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619651
- Sponsor's protocol ID
- 2025/519
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tulgar S, Senturk O, Thomas DT, Deveci U, Ozer Z. A new technique for sensory blockage of posterior branches of sacral nerves: Ultrasound guided sacral erector spinae plane block. J Clin Anesth. 2019 Nov;57:129-130. doi: 10.1016/j.jclinane.2019.04.014. Epub 2019 Apr 15. No abstract available.
PubMed 30999197Sancak Demirci NB, Kesici S, Oba S, Turk HS, Cinar AS, Demir M. Comparison of analgesic efficacy of sacral erector spinae plane block and caudal block in pediatric patients undergoing hypospadias repair surgery. J Pediatr Urol. 2025 Aug;21(4):885-893. doi: 10.1016/j.jpurol.2025.03.010. Epub 2025 Mar 20.
PubMed 40180872Kaya C, Dost B, Tulgar S. Sacral Erector Spinae Plane Block Provides Surgical Anesthesia in Ambulatory Anorectal Surgery: Two Case Reports. Cureus. 2021 Jan 9;13(1):e12598. doi: 10.7759/cureus.12598.
PubMed 33585088Bansal T, Yadav N, Singhal S, Kadian Y, Lal J, Jain M. Evaluation of USG-guided novel sacral erector spinae block for postoperative analgesia in pediatric patients undergoing hypospadias repair: A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2024 Apr-Jun;40(2):330-335. doi: 10.4103/joacp.joacp_418_22. Epub 2023 Jul 29.
PubMed 38919450
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Sacral Erector Spinae Plane Block and Caudal Epidural Block for Postoperative Analgesia in Pediatric Hypospadias Surgery
- ClinicalTrials.gov ID
- NCT07619651
- Acronym / sponsor ID
- 2025/519
- Conditions
- Hypospadias, Postoperative Pain
- Keywords
- Sacral Erector Spinae Plane Block, Caudal Epidural Block, Hypospadias Surgery, Postoperative Analgesia, Pediatric Urology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 2 Jun 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.
Hypospadias surgery in pediatric patients requires effective postoperative analgesia to ensure patient comfort and reduce perioperative stress. Caudal epidural block is widely used for analgesia in pediatric urological procedures; however, alternative regional techniques such as the sacral erector spinae plane (ESP) block have recently gained attention.
This prospective comparative study aims to compare the analgesic efficacy of sacral ESP block and caudal epidural block in pediatric patients undergoing hypospadias surgery. Participants will be allocated to receive either sacral ESP block or caudal epidural block according to the study protocol.
The primary outcome will be postoperative pain scores within the first 24 hours after surgery. Secondary outcomes will include total analgesic consumption, time to first rescue analgesia, and block-related complications.
Detailed description
Hypospadias is one of the most common congenital urogenital anomalies in pediatric patients and typically requires surgical correction in early childhood. Effective postoperative pain management is essential to improve patient comfort, reduce perioperative stress, and prevent complications. Inadequate pain control in pediatric surgical patients has been associated with increased morbidity, prolonged hospital stay, and delayed recovery.
Caudal epidural block is widely used for postoperative analgesia in pediatric urological surgery due to its ease of application and high success rate. However, it has limitations such as relatively short duration of analgesia and potential side effects including motor block, urinary retention, and lower extremity weakness. Therefore, alternative regional anesthesia techniques that may provide longer-lasting analgesia with fewer side effects are of increasing interest.
The erector spinae plane (ESP) block is a relatively novel regional anesthesia technique that provides both somatic and visceral analgesia and can be applied at different spinal levels. The sacral approach to ESP block has recently been described as a potential alternative for lower abdominal and urogenital surgeries. However, evidence regarding its effectiveness in pediatric hypospadias surgery remains limited.
This prospective comparative study aims to compare the analgesic efficacy, postoperative analgesic requirements, and block-related complications of sacral erector spinae plane block and caudal epidural block in pediatric patients undergoing hypospadias repair surgery.
Patients aged between 6 months and 7 years with ASA physical status I-II scheduled for hypospadias repair will be included. Participants will be allocated into either the sacral ESP block group or the caudal epidural block group according to the study protocol.
All patients will receive standardized general anesthesia and monitoring. Regional blocks will be performed under general anesthesia prior to surgery. In the sacral ESP block group, the block will be performed under ultrasound guidance using an in-plane technique, and 0.25% bupivacaine at a dose of 0.5 mL/kg will be administered. In the caudal epidural block group, the block will be performed using a standard technique with 0.25% bupivacaine at a dose of 0.5 mL/kg.
Postoperative pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale at 30 minutes, and at 1, 4, 12, and 24 hours after surgery. Total postoperative analgesic consumption, time to first rescue analgesia, and block-related complications (including motor weakness, nausea and vomiting, hypotension, bradycardia, pruritus, intravascular injection, and bleeding) will be recorded.
Statistical analysis will be performed using appropriate tests according to data distribution, with a significance level set at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be allocated to one of two parallel groups to receive either sacral erector spinae plane block or caudal epidural block according to the study protocol.
| Arm | Type | Receives |
|---|---|---|
| Sacral ESP Block Group | Experimental | Procedure: Sacral ESP BlockPatients receiving ultrasound-guided sacral erector spinae plane block for postoperative analgesia |
| Caudal Epidural Block Group | Active comparator | Procedure: Caudal Epidural BlockPatients receiving caudal epidural block for postoperative analgesia |
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male patients aged between 6 months to 7 years
- Scheduled for hypospadias repair surgery
- ASA physical status I-II
- No known allergy to local anesthetic agents
- No contraindications to peripheral nerve blocks
Key exclusion criteria (5 listed)
- Known congenital coagulopathy
- Known allergy to local anesthetic agents
- Severe systemic disease (ASA III-IV)
- Severe organ failure
- Neurological disorders
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 ESP BlockSacral erector spinae plane block will be performed under ultrasound guidance in pediatric patients under general anesthesia. A linear ultrasound probe will be placed in the longitudinally over the sacral region to identify the sacral median crest and erector spinae muscle. Using an in-plane technique, a block needle will be advanced in a cranial-to-caudal direction, and after negative aspiration, 0.25% bupivacaine at a dose of 0.5 mL/kg will be injected beneath the erector spinae muscle at the level of the sacral vertebra. The injection will be performed incrementally with intermittent aspiration to avoid intravascular injection. | Procedure or surgery | Sacral ESP Block Group |
| Caudal Epidural BlockCaudal epidural block will be performed in pediatric patients under general anesthesia in the lateral decubitus position. The sacrococcygeal membrane will be identified using anatomical landmarks, and a needle will be inserted into the caudal epidural space. After negative aspiration, 0.25% bupivacaine at a dose of 0.5 mL/kg will be administered slowly. Intermittent aspiration will be performed during injection to minimize the risk of intravascular or intrathecal injection. | Procedure or surgery | Caudal Epidural Block Group |
Primary outcome
Postoperative Pain Score Assessed by FLACC Scale
Time frame: Within the first 24 hours after surgery
Postoperative pain intensity will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale in pediatric patients undergoing hypospadias repair surgery. The FLACC scale consists of five behavioral categories (Face, Legs, Activity, Cry, Consolability), each scored from 0 to 2 points, resulting in a total score ranging from 0 to 10. Higher scores indicate greater pain intensity. FLACC scores will be recorded at 30 minutes, and at 1, 4, 12, and 24 hours after surgery. Rescue analgesia will be administered when the FLACC score is 4 or greater.
3 secondary outcomes
Time to First Rescue Analgesia
Time frame: Within the first 24 hours after surgery
Total Postoperative Analgesic Consumption
Time frame: Within the first 24 hours after surgery
Block-Related Complications
Time frame: Within the first 24 hours after surgery
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 25 Jun 2026.
- Background: PubMed 30999197Tulgar S, Senturk O, Thomas DT, Deveci U, Ozer Z. A new technique for sensory blockage of posterior branches of sacral nerves: Ultrasound guided sacral erector spinae plane block. J Clin Anesth. 2019 Nov;57:129-130. doi: 10.1016/j.jclinane.2019.04.014. Epub 2019 Apr 15. No abstract available.
- Background: PubMed 40180872Sancak Demirci NB, Kesici S, Oba S, Turk HS, Cinar AS, Demir M. Comparison of analgesic efficacy of sacral erector spinae plane block and caudal block in pediatric patients undergoing hypospadias repair surgery. J Pediatr Urol. 2025 Aug;21(4):885-893. doi: 10.1016/j.jpurol.2025.03.010. Epub 2025 Mar 20.
- Background: PubMed 33585088Kaya C, Dost B, Tulgar S. Sacral Erector Spinae Plane Block Provides Surgical Anesthesia in Ambulatory Anorectal Surgery: Two Case Reports. Cureus. 2021 Jan 9;13(1):e12598. doi: 10.7759/cureus.12598.
- Background: PubMed 38919450Bansal T, Yadav N, Singhal S, Kadian Y, Lal J, Jain M. Evaluation of USG-guided novel sacral erector spinae block for postoperative analgesia in pediatric patients undergoing hypospadias repair: A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2024 Apr-Jun;40(2):330-335. doi: 10.4103/joacp.joacp_418_22. Epub 2023 Jul 29.
- 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.
ÖZLEM ÖZ GERGİN principal investigator
Erciyes University Faculty of Medicine
RABİA BÜŞRA SATICI study director
Erciyes University Faculty of Medicine
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 ESP Block and Caudal Epidural Block in people with Hypospadias and Postoperative Pain, run by TC Erciyes University 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 6 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: looking for participants now, as of the sponsor's last update on 25 Jun 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 ÖZLEM ÖZ GERGİN, MD (0905332466396, oozgergin@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score Assessed by FLACC Scale (time frame: Within the first 24 hours after surgery). 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 NCT07619651, which also lists 4 linked publications.
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 25 Jun 2026.