A Prospective, Double-blinded, Randomized Comparison of Ultrasound-guided Femoral Nerve Block With Lateral Femoral Cutaneous Nerve Block Versus Standard Anesthetic Management for Traumatic Femur Fracture Repair in the Pediatric Population
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Post-anesthesia Care Unit (PACU) Pain Scores
研究概览
简要总结
The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing traumatic femur fracture repair who have received either a femoral nerve block with a lateral femoral cutaneous nerve block or a standard anesthetic for analgesia.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I or II
- •Weight greater than or equal to 10kg
- •Presenting for repair of traumatic femur fracture
排除标准
- •ASA physical status > II
- •Co-morbid diseases (cardiac, pulmonary, neurological disease)
- •Patients having concomitant procedures
- •Abnormal neurovascular examination in the injured leg
- •Presence of vascular compromise in the affected lower extremity
- •Mechanism of sustained injury via crush injury
- •Use of therapeutic dose anticoagulants or presence of a bleeding disorder
研究组 & 干预措施
Femoral Nerve Block
Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg
干预措施: Ropivicaine (Drug)
Femoral Nerve Block
Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg
干预措施: Epinephrine (Drug)
结局指标
主要结局
Post-anesthesia Care Unit (PACU) Pain Scores
时间窗: 30 mins after surgery
Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain.
次要结局
- Intraoperative End-tidal Isoflurane %(1 1/2 hr.)
- Time to First Opioid Dose(From PACU discharge until first opioid dose on the ward, assessed up to 24 hours)
研究者
Nicole Elsey
Clinical Assistant Professor
Nationwide Children's Hospital