A Prospective Randomized Trial Comparing Extrapleural Intercostal Local Anesthesia Versus Thoracic Epidural for the Managment of Acute Post Thoracotomy Pain
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- pain control-visual analog pain score
研究概览
简要总结
We will compare thoracic epidural anesthesia which is presently used for management of pain after thoracotomy to an intra-operatively placed extrapleural intercostal catheter. The study wil be double blinded and prospective.
详细描述
The aim of this study is to evaluate the efficacy of thoracic epidural vs. continuous extra-pleural intercostal local anesthesia for the treatment of post thoracotomy pain in adult patients. Study patients will be randomized between the thoracic epidural and continuous extrapleural catheter groups[Figure 1]. Because thoracic epidural anesthesia is the gold standard but continuous extrapleural intercostal local anesthesia is potentially easier and less prone to complications, the study will be structured as an "equivalence study". The null hypothesis (Ho) is that continuous intercostal nerve blockade is worse than epidural for post-thoracotomy pain management. Therefore, the alternative hypothesis (Ha) is then that continuous intercostal nerve blockade is equal to or better than epidural for post-thoracotomy pain management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral thoracotomy
- •Video Assisted thoracotomy with high likely hood of converting to open thoracotmoy
排除标准
- •Bilateral thoracotomy
- •Planned bilateral thoracotomy
- •Planned chest wall resection
- •Planned combined thoracotomy and laparotomy procedure
- •VATS procedure without conversion to unilateral thoracotomy
- •Emergency operation
- •Critically ill patients
- •Patients who require an assistive device (i.e. cane, walker, or wheel chair) for mobility
- •Patients who are unable to give informed consent
- •Patients with preoperative chronic back or chest wall pain
- •Empyema or other infective condition increasing the risk of epidural infection
- •Coagulopathy
- •Decision of the surgeon or anesthesiologist, or choice of the patient
- •Infection at site of epidural placement
- •Patients with other co morbidities which exclude thoracic epidural placement
- •Patients under the age of 18 years
结局指标
主要结局
pain control-visual analog pain score
时间窗: post surgery monitoring
次要结局
- respiratory measurements (FEV1, PEF), pain score, nausea and vomiting, opiod usage as adjunct to primary treatmetn modalities(post surgery monitoring)