A Prospective, Randomized, Double-blind, Placebo-controlled, Crossover Trial of Epidural Analgesia Versus a Surgically-placed Fascia Iliaca Compartment Catheter for Postoperative Pain After Periacetabular Osteotomy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Number of days until all pre-defined readiness-to-discharge criteria for hip surgery are met
研究概览
简要总结
The investigators are investigating two ways of treating pain after hip surgery. One way is though a thin tube (called a catheter), and it is placed into the back so that pain-numbing drugs can reach the nerves near the backbone. This is called an "epidural" catheter. Another way is to place the catheter close to the hip, where the surgery is done, so that the pain-numbing drugs can reach some of the nerves more locally. This is called a "fascia iliaca compartment" catheter.
The investigators do not know which way is best to treat pain, or has fewer side effects, or allows a patient to leave hospital faster. Usually, patients would receive only one type of catheter for pain relief. To do this comparison, the investigators would place both catheter types, so that patients help us tell which one works better.
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, Care Provider)
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight >40 kg
- •Radiographic evidence of hip dysplasia amenable to unilateral surgical treatment by periacetabular osteotomy
- •Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale >4/20
- •Age between 15 and 35 years
- •Good or excellent preoperative joint congruency
排除标准
- •Hematologic or neurologic contraindications to epidural catheter placement
- •Significant renal, hepatic, or cardiac disease
- •Peptic ulcer disease
- •Bleeding disorders
- •Severe asthma
- •Hypersensitivity to non-steroidal antiinflammatory drugs
- •Developmental delay
- •History of substance abuse
- •Chronic opioid use
- •Chronic pain in non-hip locations
结局指标
主要结局
Number of days until all pre-defined readiness-to-discharge criteria for hip surgery are met
时间窗: 1-5 days
1. Numerical pain rating score \<4 at rest, and \<6 with movement, 2. Independence from intravenous opioids for 12 hours, and 3. Ambulation at least 30 m, without a time limit
次要结局
未报告次要终点
研究者
Luke Y. Wang
Instructor in Anesthesia
Boston Children's Hospital