An interventional study of Sacral ESP Block and Caudal Epidural Block in Hypospadias and Postoperative Pain, sponsored by TC Erciyes University. Recruiting at 1 site in Turkey (Türkiye). Open to male participants aged 6 Months to 7 Years. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by TC Erciyes University · Not applicable, Interventional, and Treatment
Among 12 studies in Hypospadias with a site in Turkey — 3 open to participants now, 3 under way, none of them phase 3. Hypospadias · Turkey.
Among the 12 studies in Hypospadias with a site in Turkey, this one is one of 2 that started in 2026, is one of 8 with no phase, and was the 10th registered.
123 studies on the registry are indexed under Hypospadias; 34 are open to participants now.
Browse Hypospadias studies →3 of the 12 studies in Hypospadias with a site in Turkey are open now. Recruiting first, the newest first:
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Sites in Turkey
Necmi Kadıoğlu Hospital · Sites in Turkey, North Macedonia, Russian Federation
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 20 Hypospadias studies recruiting now, 4 (20%) set no upper age limit and 16 (80%) stop at 75 or younger; 18 take children under 18; 3 take healthy volunteers.
This study: 6 Months to 7 Years · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 2 started in 2026.
This study's planned enrollment of 60 is below the median of 70 across 97 interventional studies indexed under Hypospadias.
Median enrollment 69 across the 8 interventional studies, 41 across the 4 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
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None of the 12 has an industry lead sponsor. The 10 most frequent:
TC Erciyes University is the lead sponsor of 349 studies on the registry; 74 are open to participants now.
TC Erciyes University has 1 study filed under Hypospadias — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Hypospadias with a site in Turkey, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receiving ultrasound-guided sacral erector spinae plane block for postoperative analgesia
Procedure: Sacral ESP Block
Patients receiving caudal epidural block for postoperative analgesia
Procedure: Caudal Epidural Block
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 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.
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.
Time frame: Within the first 24 hours after surgery
Time to First Rescue Analgesia
Time from the end of surgery to the first administration of rescue analgesic medication will be recorded.
Time frame: 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.
Time frame: 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.
Time frame: Within the first 24 hours after surgery
Plan to share: No
Started Jan 2026 (actual). Primary completion is estimated for Sep 2026, 7 months after the start.
Of 60 non-industry interventional studies with no phase under Hypospadias, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 39. This study's planned 7 months is below that.
Counting every sponsor, half of 60 studies reached it within 15 months; a quarter within 8 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
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