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
- 1
- 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
研究组 & 干预措施
Study Arm
Study Arm: Surgery with intercostal Cryoanalgesia + Standard of Care (thoracic epidural)
干预措施: Thoracic Epidural (Procedure)
Control Arm
Control Arm: Surgery without intercostal Cryoanalgesia + Standard of Care (thoracic epidural)
干预措施: Thoracic Epidural (Procedure)
Study Arm
Study Arm: Surgery with intercostal Cryoanalgesia + Standard of Care (thoracic epidural)
干预措施: Intercostal Cryoanalgesia (Procedure)
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