Erector Spinae Plane Block for Congenital Hip Dislocation Surgery: Randomized Controlled Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Face, Legs, Activity, Cry and Consolability Score (FLACC)
研究概览
简要总结
Developmental dysplasia of the hip (DDH) is one of the major disorder of the pediatric population with an incidence of 3 to 5 per 1000 children. Open surgical reduction of congenital hip dislocation (CHD) is typically performed after an ineffective closed reduction or older than 18 months. Multiple femoral or pelvic osteotomies and tenotomies are performed during this surgical treatment and cause severe postoperative pain. The aim of this study was to evaluate the analgesic effect of ultrasound guided erector spinae plane block (ESP) in pediatric patients undergoing CHD surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologist's physiologic state I-II patients undergoing hip dislocation surgery
排除标准
- •chronic pain
- •bleeding disorders
- •renal or hepatic insufficiency
- •patients on chronic non-steroidal anti-inflammatory medications
- •emergency cases
- •Incomplete patient forms
- •infection of the skin at the site of needle puncture area
- •patients with known allergies to any of the study drugs
- •ASA III-IV
研究组 & 干预措施
Saline + Placebo
Ultrasound guided 0.5 ml/kg saline injection to erector spinae plane
干预措施: Saline Solution (Drug)
ultrasound guided erector spinae plane block
Ultrasound guided 0.5 ml/kg % 0.250 bupivacaine injection to erector spinae plane
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Face, Legs, Activity, Cry and Consolability Score (FLACC)
时间窗: Postoperative first 24hour
FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
次要结局
- Need for analgesic(24 hour)
- Need for rescue analgesic(2 hour)
研究者
Ali Ahiskalioglu
Principal Investigator
Ataturk University