Early Percutaneous Cryoablation for Pain Control After Rib Fractures Among Elderly Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Early Percutaneous Cryoablation for Pain Control After Rib Fractures Among Elderly Patients

Conditions
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Rib Fractures

Intervention / Treatment
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* Radiation: Cryoneurolysis
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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 Exclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We are proposing a prospective, randomized trial evaluating efficacy of image-guided percutaneous intercostal cryoneurolysis (pICN) for pain control after traumatic rib fractures in persons >=65 years. Eligible patients would be enrolled by the trauma service after consent or assent is obtained. Patients will be randomized to either pICN within 72 hours of presentation or existing standard-of-care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Image-guided percutaneous ICN (pICN): Group A<br>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. | Radiation: Cryoneurolysis<br>* Patients will be offered a minimally invasive solution known as cryoneurolysis. By directly applying a cold cryoneurolysis probe to the nerves the axon is destroyed, resulting in Wallerian degeneration of the distal nerve without distorting epineurial or perineurial tissue. Application of cryoneurolysis will help reduce the amount of narcotics the patient would need to take and instead provide them longer term pain control with minimal risk.<br>|
| Active Comparator: Standard-of Care : Group B<br>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. | Other: Standard of Care<br>* Patients will be provided regular standard of care at the Stanford Hospital with long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Pain Assessed by Numeric Pain Score | The patient will be asked to verbalize their numeric pain score daily after discharge and at follow-up visits. Pain measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain. | 12 months | 
| Length of hospital stay | The Length of Stay will be obtained from the patient's chart after discharge and will depend on the level of care required for recovery from their injuries. | Up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality | Will be obtained from chart review after discharge | 1 month | 
| Number of participants requiring ICU admission | Will be obtained from chart review after discharge | 1 month | 
| Use of Narcotic Equivalents | Oral narcotic equivalents on day of discharge. | 12 months | 
| 30-day rib-specific readmission | Incidence of readmission. The patient will be admitted back to the hospital if pain level relates to rib-specific injuries such as hemothorax and pneumonia. | 1 month | 
| The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score | The McGill Pain Questionnaire (MPQ) is a validated 20 question instrument to quantify subjective pain and the scoring system yields a Pain Rating Index (PRI) score between Mild, Moderate or Severe. The questionnaire will be administered to the patient by study/ clinical staff upon discharge. The scoring system yields a pain rating index (PRI) score between 0 and 50 used to temporally track pain, higher scores correspond to higher pain levels. | 12 months | 
| The Glasgow Outcome Scale Extended (GOS-E) Score | The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status into one of five categories: Dead, Vegetative State, Severe Disability, Moderate Disability or Good Recovery. The Extended GOS (GOSE) provides more detailed categorization into eight categories by subdividing the categories of severe disability, moderate disability and good recovery into a lower and upper category: Death (D) Vegetative state (VS) Lower severe disability (SD -) Upper severe disability (SD +) Lower moderate disability ( MD -) Upper moderate disability ( MD +) Lower good recovery (GR -) Upper good recovery (GR +) The questionnaire will be administered to the patient by study/clinical staff upon discharge. | 12 months | 
| Short Form (SF-12) Health Survey Scale Score | The 12-Item Short-Form Health Survey is a widely used composite score used to gauge overall health. The composite score is based on 8 domains scores contained in the SF-12 questionnaire, which will be administered to the patient by study/clinical staff upon discharge. Score ranges from 1 (Excellent) to 5 (Poor) , 1 (Yes, limited a lot) to 3 (No, not limited at all), 1 (Yes) 2 (No), 1 (Not at all) to 5 (Extremely), 1 (All of the time) to 6 (None of the time) and 1 (All of the time) to 5 (None of the time). | 12 months |