Randomized, Single-Blinded, Controlled Trial Using Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy: ICE Study
试验速览
- 阶段
- 不适用
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Total narcotic use post-thoracotomy.
研究概览
简要总结
The ICE Study study will compare standard therapy (thoracic epidural) versus a novel approach (Cryoanalgesia combined with thoracic epidural) in subjects undergoing unilateral thoracotomy.
详细描述
The ICE Study is a single institution pilot study designed to compare standard therapy (i.e., thoracic epidural) versus a novel approach (i.e., Cryoanalgesia combined with thoracic epidural) to address the need for better management of acute and long-term pain in the general thoracic surgery patient population. The study's primary objective will be to demonstrate if the new intraoperative pain management approach [i.e., intercostal Cryoanalgesia in conjunction with thoracic epidural] provides superior short-term and long-term analgesia efficacy in patients undergoing unilateral thoracotomy as compared to the current institutional standard of care (i.e., thoracic epidural). Patients will be randomized in a 1:1 design.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing unilateral thoracotomy for non-cardiac surgery
- •Age 18-85 years of age; male or female
- •Acceptable surgical candidate including use of general anesthesia
- •Willing and able to provide written informed consent
- •Willing and able to return for scheduled follow-up visits
排除标准
- •Prior major surgery within the last 6-months
- •Documented psychiatric disease
- •Documented chronic pain syndrome
- •Current use of prescription opioids
- •Documented history of substance abuse
- •Functional disability or impairment (ECOG score = 0 or 1)
- •Current pregnancy
- •Patients currently enrolled in another research study that could directly affect results of either study
- •Physical or mental condition that would interfere with patient's self-assessment of pain
- •A medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conduct of the study or interferes with the pain assessments
结局指标
主要结局
Total narcotic use post-thoracotomy.
时间窗: 6 months
The primary outcome measure of this study is to determine if the addition of Cryoanalgesia to standard of care post thoracotomy pain control, results in decreased pain and/or narcotic use at time points ranging from perioperative to six months post discharge.
次要结局
- Quality of Life (SF-36) changes from baseline to 6-months(6 months)
- Allodynia Assessment(6 months)
- Mankoski Pain Scale Assessment of post-thoracotomy pain(6 months)
- Visual Analog Scale (VAS) Assessment of post-thoracotomy pain(6 months)
研究者
Joseph S. Friedberg, MD
Professor; Surgeon-in-Chief, UMMS Division of Thoracic Surgery
University of Maryland, Baltimore