Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis for Pain Control (Trauma-PC2-study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Daily Numeric Pain Score
研究概览
简要总结
The purpose of this research study is to examine the effectiveness of using the Iovera Smart Time 190, for ultrasound-guided cryoneurolysis, in trauma patients 18-64 years old with rib fractures that are not candidates for surgical stabilization. This will offer patients the benefits of cryoneurolysis of the intercostal nerves, thereby providing short and long term pain control while their ribs heal.
The Iovera Smart Tip 190 is FDA approved for cryoneurolysis.
详细描述
The purpose of this research study is to examine the effectiveness of using the Iovera Smart Time 190, for minimally invasive ultrasound-guided cryoneurolysis, in trauma patients 18-64 years old with rib fractures that are not candidates for surgical stabilization. This procedure will offer patients the benefits of cryoneurolysis (freezing) of the intercostal nerves, thereby providing short and long term pain control while their ribs heal.
Patients in the intervention arm will receive cryoneurolysis via the Iovera device and patients in the control arm will receive standard of care which typically includes multimodal pain therapy and pulmonary toilet. Short and long term pain relief will be compared among both arms.
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
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 to 64 years with any acute rib fracture between rib 3 and rib 9
- •Pain score equal to or greater than 5 with deep inspiration
- •Presenting and admitted to Stanford Adult Emergency Department, having a trauma consult, and being admitted to the trauma floors of Stanford Healthcare (SHC) for their inpatient stay
排除标准
- •Radiographic evidence of metastasis to ribs
- •Glasgow Coma Scale (GCS) score <13
- •Patients undergoing SSRF (Surgical stabilization of rib fractures)
- •Rib fractures located < 3cm from spinous process
- •Coagulopathy (INR >1.5, Plt < 100)
- •Other factors precluding cryoneurolysis at the attending's discretion
- •If only ribs broken are 1,2 or 10,11,12
- •Inability to be positioned for the procedure
- •If the patient has the following conditions that the manufacturer of the Iovera device advises AGAINST using the device if present: Cryoglobulinemia, Paroxysmal cold hemoglobinuria, Cold urticaria, Raynaud's disease, open and/or infected wounds at or near the treatment site.
研究组 & 干预措施
Ultrasound-guided Cryoneurolysis: Group A
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to the ultrasound-guided cryoneurolysis group within 72 hours of admission to the ED.
Intervention is ultrasound-guided cryoneurolysis of intercostal nerves creating lost lasting pain relief. Device used for cryoneurolysis is Iovera Smart tip 190
干预措施: Cryoneurolysis of Intercostal Nerves (Device)
Standard-of-Care : Group B
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to Standard of Care which typically includes multi-modal pain therapy and pulmonary toilet.
干预措施: Standard of Care (Other)
结局指标
主要结局
Daily Numeric Pain Score
时间窗: At time of discharge from hospital (up to 1 month)
Patients will be asked to verbalize their numeric pain score, measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain. Daily numeric pain score is collected on the day the patient is discharged from the hospital.
次要结局
- Number of Patients With 30-day Mortality(1 month after hospital discharge)
- Need for ICU Admission(1 month after hospital discharge)
- Number of Patients With a 30-day Rib-specific Admission(1 month after hospital discharge)
- The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Sub Scores(Collected 1, 3, 12 months (post hospital discharge))
- Short Form (SF-12) Health Survey Scale Summary Scores(Collected 1, 3, 12 months (post hospital discharge))
- Length of Hospital Stay(Up to 1 month from ED arrival)
- Daily Narcotic Equivalents(Collected at discharge (up to 1 month), 1, 3, 12 months post discharge)
- 30-day mortality(Evaluated 1 month after hospital discharge)
- Need for ICU admission(1 month after hospital discharge)
- 30-day rib-specific admission(1 month after hospital discharge)
- The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score(Collected 1, 3, 12 months (post hospital discharge))
- The Glasgow Outcome Scale Extended (GOS-E) Score(Collected 1, 3, 12 months post hospital discharge)
- Short Form (SF-12) Health Survey Scale Score(Collected 1, 3, 12 months (post hospital discharge))
- Length of hospital stay(Up to 1 month from ED arrival)
研究者
Joseph Forrester
Assistant Professor of Surgery
Stanford University