Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery

Официальное название

Comparison of Preemptive Analgesic Effect of Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery

Обзор

Randomized, parallel-group, assessor-blinded clinical trial at Tanta University Hospitals comparing ultrasound-guided sacral erector spinae plane block (sESPB) versus ultrasound-guided caudal epidural block for postoperative analgesia in male children (1-5 years) undergoing hypospadias repair. Seventy participants will be randomized 1:1 to receive sESPB or caudal block with 0.25% bupivacaine (0.5-1 mL/kg; maximum 20 mL) after induction of general anesthesia. The primary outcome is pain over the first 24 hours, assessed using the FLACC scale at prespecified time points. Secondary outcomes include total opioid consumption, time to first rescue analgesia, postoperative nausea and vomiting, parent/guardian satisfaction, hemodynamic trends, and predefined adverse effects (e.g., motor weakness, urinary retention, respiratory depression, hematoma, infection at injection site). Perioperative care is standardized; rescue pethidine is administered when FLACC ≥4. The trial evaluates whether sESPB provides superior or comparable analgesia with fewer adverse effects than caudal block.

Подробное описание

Randomized, parallel-group, assessor-blinded clinical trial at Tanta University Hospitals comparing ultrasound-guided sacral erector spinae plane block (sESPB) versus ultrasound-guided caudal epidural block for postoperative analgesia in male children (1-5 years) undergoing hypospadias repair. Seventy participants will be randomized 1:1 to receive sESPB or caudal block with 0.25% bupivacaine (0.5-1 mL/kg; maximum 20 mL) after induction of general anesthesia. The primary outcome is pain over the first 24 hours, assessed using the FLACC scale at prespecified time points. Secondary outcomes include total opioid consumption, time to first rescue analgesia, postoperative nausea and vomiting, parent/guardian satisfaction, hemodynamic trends, and predefined adverse effects (e.g., motor weakness, urinary retention, respiratory depression, hematoma, infection at injection site). Perioperative care is standardized; rescue pethidine is administered when FLACC ≥4. The trial evaluates whether sESPB provides superior or comparable analgesia with fewer adverse effects than caudal block.

Вмешательства

• Процедура Ultrasound-guided sacral erector spinae plane block (sESPB)
  After induction of general anesthesia, bilateral sESPB is performed under ultrasound guidance. Needle advanced to the sacral interfascial plane near the median sacral crest; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL/kg (max total 20 mL) is injected. Standardized perioperative care; rescue pethidine 0.5 mg/kg if FLACC ≥4.
• Процедура Ultrasound-guided caudal epidural block
  After induction of general anesthesia, caudal epidural injection via sacral hiatus under ultrasound guidance; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL/kg (max total 20 mL) is injected. Standardized perioperative care; rescue pethidine if FLACC ≥4.

Первичные конечные точки

• FLACC pain score (0-10) during the first 24 hours after surgery [Срок оценки: From immediately after surgery through 24 hours postoperatively: at the time of Post-Anesthesia Care Unit (PACU) arrival (0 hours), and at 30 minutes, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours after surgery.]

Вторичные конечные точки (4)

• Total opioid consumption (pethidine), 0-24 h (mg/kg) [Срок оценки: From the time of arrival to the Post-Anesthesia Care Unit (0 hours) through 24 hours after surgery.]
• Time to first rescue analgesia requirement postoperatively [Срок оценки: From the time of arrival to the Post-Anesthesia Care Unit (0 hours) until the first rescue dose, within 24 hours after surgery]
• Parent's satisfaction [Срок оценки: 24 hours postoperatively]
• Incidence of postoperative adverse events [Срок оценки: 24 hours postoperatively]

Критерии участия

Критерии включения

• Male children aged 1-5 years
• ASA physical status I-II
• Scheduled for elective hypospadias repair under general anesthesia
• Parent or legal guardian provides written informed consent
• Able to complete postoperative assessments through 24 hours after surgery Exclusion Criteria
• Parent/guardian refusal of participation
• Coagulopathy or current anticoagulant therapy
• Infection at the intended injection site (sacral/caudal region) or systemic infection
• Allergy/hypersensitivity to amide local anesthetics (e.g., bupivacaine) or study medications
• Neurologic or spinal disorders or congenital sacral anomalies affecting block safety
• Significant hepatic, renal, or cardiac disease
• Any other condition that, in the investigator's judgment, contraindicates caudal block or sacral ESPB or could interfere with safe participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Египет · 1 центр

• Tanta University Hospital — Tanta

Идентификаторы

NCT: NCT07099560 · 36264MS869/3/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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