Comparison of Preemptive Analgesic Effect of Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- FLACC pain score (0-10) during the first 24 hours after surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm A: Sacral Erector Spinae Plane Block (sESPB)
Participants receive bilateral ultrasound-guided sacral ESPB after induction of general anesthesia. Using a high-frequency linear probe, the needle is advanced to the sacral fascial plane near the median sacral crest; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL/kg (maximum total volume 20 mL) is injected. Standardized perioperative care; rescue analgesia (pethidine 0.5 mg/kg) if FLACC ≥4.
干预措施: Ultrasound-guided sacral erector spinae plane block (sESPB) (Procedure)
Arm B - Active Comparator: Caudal Epidural Block
Participants receive ultrasound-guided caudal epidural block after induction of general anesthesia. Needle introduced via the sacral hiatus under ultrasound; after negative aspiration, bupivacaine 0.25% at 0.5-1 mL/kg (maximum total volume 20 mL) is injected. Standardized perioperative care; rescue pethidine if FLACC ≥4.
干预措施: Ultrasound-guided caudal epidural block (Procedure)
结局指标
主要结局
FLACC pain score (0-10) during the first 24 hours after surgery
时间窗: 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.
The FLACC scale (Face, Legs, Activity, Cry, Consolability) is a validated behavioral pain measure. Each category is scored 0-2; the total score ranges 0-10 with higher scores indicating more pain. Scores will be recorded at rest by a blinded outcomes assessor at the prespecified time points. Rescue analgesia is IV pethidine 0.5 mg/kg when FLACC ≥4. The primary analysis compares groups across time (mixed-effects model) and/or as the time-weighted mean over 0-24 h.
FLACC pain score (0-10) during the first 24 hours after surgery
时间窗: 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.
The FLACC scale (Face, Legs, Activity, Cry, Consolability) is a validated behavioral pain measure. Each category is scored 0-2; the total score ranges 0-10 with higher scores indicating more pain. Scores will be recorded at rest by a blinded outcomes assessor at the prespecified time points. Rescue analgesia is IV pethidine 0.5 mg/kg when FLACC ≥4. The primary analysis compares groups across time (mixed-effects model) and/or as the time-weighted mean over 0-24 h.
次要结局
- Total opioid consumption (pethidine), 0-24 h (mg/kg)(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(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(24 hours postoperatively)
- Incidence of postoperative adverse events(24 hours postoperatively)
- Total opioid consumption (pethidine), 0-24 h (mg/kg)(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(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(24 hours postoperatively)
- Incidence of postoperative adverse events(24 hours postoperatively)
研究者
Ghada Magdy Ahmed Elfekey
Resident of Anesthesia, Surgical Intensive Care and Pain Management
Tanta University