Rib Fractures
Conditions
Keywords
rib fractures, CT guided cryoneurolysis
Brief summary
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
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.
Interventions
RADIATIONCryoneurolysis
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.
OTHERStandard of Care
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.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Pain Assessed by Numeric Pain Score | Hospital discharge (up to 1 month) | The patient will be asked to verbalize their numeric pain score on the day of hospital discharge. Pain is 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Form (SF-12) Health Survey Scale Score | 1 month, 3 months, 12 months (all from hospital discharge) | 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. The composite score is split into two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Both scores are on a scale of 0-100, with higher scores representing better mental health-related (MCS) or physical health-related (PCS) quality of life. The means of both scores are standardized to 50 with a standard devation of 10. |
| 30-day Mortality | 1 month after hospital discharge | Will be obtained from chart review after discharge |
| Number of Participants Requiring ICU Admission | 1 month after hospital discharge | Will be obtained from chart review after discharge |
| Length of Hospital Stay | Up to 1 month | 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. |
| Use of Narcotic Equivalents | Hospital discharge (up to 1 month), 1 month, 3 months, 12 months after hospital discharge | Daily oral narcotic equivalents |
| Number of Participants With a Rib-specific Readmission Within 30 Days of Discharge | 1 month after hospital discharge | The patient will be admitted back to the hospital if pain level relates to rib-specific injuries such as hemothorax and pneumonia. |
| The Glasgow Outcome Scale Extended (GOS-E) Score | 1 month, 3 months, 12 months (all from hospital discharge) | 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: 1. Death (D) 2. Vegetative state (VS) 3. Lower severe disability (SD -) 4. Upper severe disability (SD +) 5. Lower moderate disability ( MD -) 6. Upper moderate disability ( MD +) 7. Lower good recovery (GR -) 8. Upper good recovery (GR +) The questionnaire will be administered to the patient by study/clinical staff upon discharge. |
| The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score | 1 month, 3 months, 12 months (all from hospital discharge) | 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 at 1-month, 3-month, and 12-month follow-ups. Using the questionnaires, McGill Present Pain Intensity (PPI), Sensory, Affective, and Visual Analogue Scale scores will be calculated and reported. PPI and Visual Analogue Scale scores are on a scale of 0-10, Sensory scores are on a scale of 0-33, and Affective scores are on a scale of 0-12. Higher scores indicate worse pain for all McGill scores. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoseph D Forrester, MD
Stanford University
PRINCIPAL_INVESTIGATORNishita Kothary, MD
Stanford University
Participant flow
Recruitment details
Patients were pre-screened to determine if they met eligibility criteria. If this was met, they were approached by a CRC for in-person consent at Stanford Healthcare (SHC). The enrollment period was from June 1, 2021, to April 15, 2024.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 79.5 years |
| Daily opioid equivalents in first 24 hours | 25 MMEs |
| Highest pain score in first 24 hours | 8.04 points STANDARD_DEVIATION 1.64 |
| Race/Ethnicity, Customized Race Asian | 12 Participants |
| Race/Ethnicity, Customized Race Black of African American | 2 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Race Unknown or not reported | 12 Participants |
| Race/Ethnicity, Customized Race White | 83 Participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 56 | 3 / 54 |
| other Total, other adverse events | 9 / 56 | 24 / 54 |
| serious Total, serious adverse events | 13 / 56 | 11 / 54 |
Outcome results
None listed