On-Q Pump vs Epidural for Postoperative Pain Control in Children Undergoing Oncologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Additional narcotic use
研究概览
简要总结
Open abdominal and pelvic surgery or thoracotomy (open chest surgery) is frequently performed for tumor excision in children. Post-operative pain management regimens are often at the discretions of the attending surgeon and may include opiods, patient administered analgesia (PCA), epidural catheters, subcutaneous analgesia catheters or NSAIDS to control incisional pain. Currently, both epidural or subcutaneous analgesia catheters (On-Q pumps) are commonly used for children undergoing these operations, at the discretion of the surgeon. There are no studies comparing these regimens in children. The purpose of this study is to compare postoperative pain control of the two strategies.
详细描述
The study design is a randomized, controlled trial to compare the effectiveness of on-q pump subcutaneous incisional analgesia to epidural analgesia for postoperative pain relief in children undergoing open abdominal, thoracic, or pelvic operations for oncologic purposes. The patient and treating team will be blinded to the pain control device. The primary outcome is additional narcotic usage for 3 post-operative days, and secondary outcomes are pain scores for 3 post-operative days, post-surgical day of ambulation, time to regular diet, infectious complications (UTI, wound infection or pneumonia), and hospital length of stay. Outcomes from both groups will be directly compared in order to determine whether one strategy provides more effective pain control with less complications than the other, or whether they are equivalent.
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)
盲法说明
The patient, family and clinical care team (nurses, residents, physician assistants) will be blinded, as well as the research team collecting outcomes. The surgeons (including primary investigator) will not be blinded as will be placing the device.
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight > 5kg
- •Age younger than 19 years of age
- •Planned abdominal, pelvic or thoracic operation for an oncologic indication
排除标准
- •Patients deemed inappropriate for placement of epidural by anesthesiologist
- •Minimally invasive operation
- •Biopsy through limited incision
- •History of chronic narcotic or opioid use
- •History of drug abuse
结局指标
主要结局
Additional narcotic use
时间窗: 3 days
Mg of additional narcotics used for 3 post-operative days
次要结局
- Pain scores(3 days)
- Days to ambulation(0-5 days)
- Days to initiation of regular diet(0-5 days)
- Development of postoperative infection(0-5 days)
研究者
Bindi Naik-Mathuria
Associate Professor
Baylor College of Medicine