NCT05157516已完成3 期
Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients: A Prospective Randomized Controlled Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
The study will compare Ultrasound-Guided Lumbar Erector Spinae Plane Block and caudal block for Postoperative Analgesia in Hip and Proximal Femur Surgery in pediatric patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-II.
- •Scheduled to undergo hip or proximal femur surgeries.
排除标准
- •Refusal of participation by parents or caregivers
- •Known local anesthetic (LA) drug sensitivity
- •Bleeding disorders with INR > 1.5 and/or platelets < 100,000/mm
- •Skin lesions or wounds at the site of proposed needle insertion.
结局指标
主要结局
Pain score
时间窗: 2 hours post-operatively
By using face, legs, activity, and cry consolability scale \[FLACC \] FLACC scale will be measured as following: Each category (face,legs,activity, and cry consolability) is scored on the 0-2 scale which results in a total score of 0-10. Assessment of the final score: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
次要结局
- Block failure rate(First hour postoperatively)
- pain scores(at 2 hour intervals during the first 24 hours postoperatively)
- Duration of the block(UP to 48 hours postoperatively)
- Degree of contralateral motor blockage and lower limb weakness(UP to 48 hours postoperatively)
- Block performance time(Preoperative)
- The incidence of adverse effects(Up to one week after the block)
研究者
AbdElKhalik Mahmoud Shaban
Lecturer of anaesthesia
Cairo University
研究点 (1)
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