Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Peri-operative pain scores between different surgical incisions (posterolateral thoracotomy vs thoracoscopy)
研究概览
简要总结
The researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. The research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal nerve block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who could receive cryoablation in an elective open thoracic (posterolateral thoracotomy) or minimally invasive (thoracoscopy, including robotic) procedures at Michigan Medicine
- •Patient is opioid naïve
排除标准
- •Patients who are pregnant
- •Patients with cognitive impairment
- •Patients with psychological disorders
- •Patients with prior thoracic surgery
- •Patients with fibromyalgia
- •Patients with redo ipsilateral thoracic surgery
- •Patients undergoing bilateral thoracotomy
结局指标
主要结局
Peri-operative pain scores between different surgical incisions (posterolateral thoracotomy vs thoracoscopy)
时间窗: baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop
Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity surveys
Severity of pain in the peri-operative period
时间窗: Post-op day 1 and day of hospital discharge, approximately 3 days
Pain measured using a numeric rating scale ranging from 1-10 where a higher pain score indicates more pain severity
Peri-operative nerve function between different surgical incisions (posterolateral thoracotomy vs thoracoscopy)
时间窗: baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop
assessment of feeling or touching sensations along the thoracic cavity measured using dermatone assessment
Inflammatory cytokine levels as measured by blood samples
时间窗: Pre-surgery, 6-hours after end of surgery and 24-hours after surgery
Levels are measured using blood sample collection and assay specifically assessing IL-1, IL-6, TNF-a
Inflammatory cytokines (IL-1, IL-6, TNF-a) levels correlations to pain score
时间窗: Pre-surgery, 6-hours after end of surgery and 24-hours after surgery
Correlations with the pain scores from outcome #1
次要结局
- Cost (including postoperative epidural management, narcotic pain medication, and outpatient pain management)(Up to 180-days postop)
- Quality of life score as measured by SF-36 Health questionnaire(baseline (prior to surgery), day of hospital discharge, approximately 3 days, 30-days, 90-days and 180-days post-op.)
- Workflow/time(Up to 180-days postop)
研究者
Rishindra Reddy
Research Professor of Thoracic Surgery
University of Michigan