Effect of Ultrasound-Guided External Oblique Intercostal Fascial Plane Block in Pediatric Patients Undergoing Otoplasty With Rib Cartilage Graft
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total opioid consumption within 24 hours after surgery
研究概览
简要总结
This randomized controlled trial aims to evaluate the effect of ultrasound-guided external oblique intercostal (EOI) fascial plane block on postoperative pain control and recovery in pediatric patients undergoing otoplasty with rib cartilage graft under general anesthesia. Participants aged 13 to 18 years will be randomly assigned to receive either EOI block with 0.2% ropivacaine or no block. Primary outcome is total opioid consumption within 24 hours after surgery. Secondary outcomes include NRS pain scores, incentive spirometry performance, incidence of atelectasis, and patient satisfaction.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Pediatric patients aged 13 to 18 years undergoing otoplasty with rib cartilage graft under general anesthesia at Seoul National University Children's Hospital
- •Written informed consent obtained from parent or legal guardian, and assent from the patient
排除标准
- •Unstable vital signs before surgery (heart rate <50 or >150 beats/min, systolic blood pressure <80 mmHg or >160 mmHg)
- •Known hypersensitivity to ropivacaine or other amide-type local anesthetics
- •Massive bleeding or shock
- •Local infection at the injection site
- •History of allergy to opioid medications
- •Severe renal dysfunction (creatinine >3.0 mg/dL)
- •Severe hepatic dysfunction (AST or ALT >120 U/L)
- •Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation
结局指标
主要结局
Total opioid consumption within 24 hours after surgery
时间窗: Within 24 hours after surgery
Total amount of opioid analgesic (fentanyl) administered via intravenous patient-controlled analgesia (IV-PCA) and additional rescue doses within 24 hours postoperatively. The total dose will be normalized to body weight (µg/kg).
次要结局
- Pain intensity during deep breathing(Up to 24 hours after surgery)
- Total non-opioid analgesic consumption(Up to 24 hours after surgery)
- Overall satisfaction with postoperative pain control(Up to 24 hours after surgery)
- Incidence of postoperative atelectasis(Up to 24 hours after surgery)
- Distribution of sensory block(At 30 minutes after PACU admission)
- Sleep quality(Night of surgery)
- Pain intensity at rest(Up to 24 hours after surgery)
- Incentive spirometry performance(Within 30 minutes after PACU arrival)
- Incidence of analgesic-related adverse events(Up to 24 hours after surgery)
研究者
Young-Eun Jang
professor
Seoul National University Hospital