Early Percutaneous Cryoablation for Pain Control After Rib Fractures Among Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Acute Pain Assessed by Numeric Pain Score
研究概览
简要总结
The purpose of this study is to provide long-term pain control for elderly patients with rib fractures in order to minimize their risk of complications and return them to baseline functional capacity
详细描述
The purpose of this study is to provide long-term pain control for elderly patients with rib fractures in order to minimize their risk of complications and return them to baseline functional capacity. In order to do this, we would offer a minimally invasive solution known as Cryoneurolysis. By directly applying cold Cryoneurolysis to the nerves, this can destroy nerve axons, resulting in Wallerian degeneration of the distal nerve without distorting epineural or perineurial tissue. The application of cryoneurolysis will help reduce the amount of narcotics the patient would need, and potentially lead to a better post-injury quality of life.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i) Patients greater than 65 years with any acute rib fracture
- •ii) Pain score equal to or greater than 5 with deep inspiration.
- •iii) Presenting and admitted to Stanford Emergency Department
排除标准
- •i) Radiographic evidence of metastasis to ribs
- •ii) Glasgow Coma Scale (GCS) score <13
- •iii) Patients undergoing SSRF
- •iv) Rib fractures located < 3cm from spinous process
- •v) Coagulopathy (INR >1.5, Pat < 100)
- •vi) Other factors precluding cryoablation at IR attending's discretion
- •vii) If only ribs broken are 1,2 or 10,11, 12
研究组 & 干预措施
Standard-of Care : Group B
Patients who were admitted after a traumatic injury, with rib fractures identified, who are >= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.
干预措施: Standard of Care (Other)
Image-guided percutaneous ICN (pICN): Group A
Patients who were admitted after a traumatic injury, with rib fractures identified, who are >= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.
干预措施: Cryoneurolysis (Radiation)
结局指标
主要结局
Acute Pain Assessed by Numeric Pain Score
时间窗: Hospital discharge (up to 1 month)
The patient will be asked to verbalize their numeric pain score daily after hospital discharge. Pain measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain. Note: The timing of hospital discharge varies by patient as these are polytrauma patients.
次要结局
- 30-day mortality(1 month after hospital discharge)
- Number of participants requiring ICU admission(1 month after hospital discharge)
- Length of hospital stay(Up to 1 month)
- Use of Narcotic Equivalents(Hospital discharge (up to 1 month), 1 month, 3 months, 12 months after hospital discharge)
- 30-day rib-specific readmission(1 month after hospital discharge)
- The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score(1 month, 3 months, 12 months (all from hospital discharge))
- The Glasgow Outcome Scale Extended (GOS-E) Score(1 month, 3 months, 12 months (all from hospital discharge))
- Short Form (SF-12) Health Survey Scale Score(1 month, 3 months, 12 months (all from hospital discharge))
研究者
Joseph Forrester
Assistant Professor of Surgery
Stanford University