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| Name | Class |
|---|---|
| Biruni University | OTHER |
| Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization | OTHER |
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This randomized controlled trial aims to compare the postoperative analgesic efficacy of ultrasound-guided Sacral Erector Spinae Plane (ESP) block versus Dorsal Penile Nerve Block (DPNB) in pediatric patients aged 1-7 years undergoing hypospadias surgery. The primary outcome is the pain score assessed by the FLACC scale at the 12th postoperative hour
Hypospadias surgery in pediatric patients can cause significant postoperative pain. While Dorsal Penile Nerve Block (DPNB) is a standard regional technique, the Sacral Erector Spinae Plane (ESP) block has emerged as a potential alternative for trunk and pelvic analgesia.
In this prospective, randomized, double-blind study, 70 pediatric patients (ASA I-II, aged 1-7 years) will be randomly assigned to receive either a Sacral ESP block or a DPNB under general anesthesia. Both blocks will be performed under ultrasound guidance using 0.25% bupivacaine, administered at a volume of 0.4 mL/kg for the Sacral ESP block and 0.4 mL/kg for the DPNB.
Postoperative pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale at 30 minutes, 1, 2, 6, 12, and 24 hours. The study aims to determine if Sacral ESP provides superior or non-inferior analgesia compared to DPNB, specifically focusing on the 12th-hour pain scores, total analgesic consumption, and time to first rescue analgesic
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacral ESP Block Group | Experimental | Patients will be placed in the lateral decubitus position. Under ultrasound guidance, the plane between the multifidus muscle and the sacral lamina (erector spinae plane) will be identified at the sacral level. A total of 0.4 mL/kg of 0.25% Bupivacaine will be injected bilaterally |
|
| Dorsal Penile Nerve Block Group | Active Comparator | Patients will be in the supine position. Under ultrasound guidance, the needle will be advanced under Buck's fascia at the penile base (pubic symphysis level). A total of 0.4 mL/kg of 0.25% Bupivacaine will be injected bilaterally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacral ESP Block Group | Procedure | Patients will be placed in the lateral decubitus position. Under ultrasound guidance, the plane between the multifidus muscle and the sacral lamina (erector spinae plane) will be identified at the sacral level. A total of 0.4 mL/kg of 0.25% Bupivacaine will be injected bilaterally |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Score (FLACC) at 12 Hours | Pain severity assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale at 30 minutes, 1, 2, 4, 6, 12 and 24 hours. The total score ranges from 0 to 10, where higher scores indicate worse pain. | 30 minutes, 1, 2, 4, 6, 12 and 24 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total Postoperative Analgesic Consumption | The cumulative amount of rescue analgesics (mg) consumed. | 24 hours post-surgery |
| Incidence of Postoperative Complications. | Presence of motor block, urinary retention, hematoma/ecchymosis at injection site, vomiting, or pruritus. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Burak Ömür | Contact | +905056215056 | bomur@medipol.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Selçuk Alver | Istanbul Biruni University Hospital, Istanbul, Turkey. | Study Chair |
| Volkan Özen | Prof. Dr. Cemil Tascioglu City Hospital, Istanbul, Turkey | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medipol University | Recruiting | Istanbul | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D007021 | Hypospadias |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Dorsal Penile Nerve Block Group | Procedure | Patients will be in the supine position. Under ultrasound guidance, the needle will be advanced under Buck's fascia at the penile base (pubic symphysis level). A total of 0.4 mL/kg of 0.25% Bupivacaine will be injected bilaterally |
|
| Up to 24 hours |
| Postoperative Pain Scores (FLACC) at Other Time Points | Pain severity assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale at 30 minutes, 1, 2, 4, 6, 12 and 24 hours. The total score ranges from 0 to 10, where higher scores indicate worse pain. | 30 minutes, 1, 2, 4, 6, 12 and 24 hours post-surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |