Rib Fractures
Conditions
Keywords
Percutaneous Cryoneurolysis
Brief summary
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.
Detailed description
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.
Interventions
DEVICECryoneurolysis of Intercostal Nerves
Patients will be offered a minimally invasive intervention procedure for pain control called cryoneurolysis using an ultrasound-guided device called the Iovera Smart Tip 190. The direct application of cold to the intercostal nerves via Iovera device produces lesions in peripheral nervous tissue to block the pain caused by rib fractures. This procedure is particularly beneficial for patients who are not candidates for surgical stabilization of their rib fractures. Application of cryoneurolysis as an analgesic will reduce the amount of narcotics patients might need and instead provide them short- or long-term pain control with minimal risk. Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
OTHERStandard of Care
Patients will be provided regular standard of care at the Stanford Hospital with short- or long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury. Standard of care for patients with rib fractures that are not eligible for surgical stabilization includes multi-modal pain therapy and pulmonary toilet. Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The investigators are proposing a prospective, randomized trial evaluating efficacy of ultrasound-guided cryoneurolysis for pain control after traumatic rib fractures in patients 18-64 years of age. Eligible patients would be enrolled by the trauma service after consent is obtained.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Numeric Pain Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Narcotic Equivalents | Collected at discharge (up to 1 month), 1, 3, 12 months post discharge | Morphine Milligram Equivalents (MME) |
| Number of Patients With 30-day Mortality | 1 month after hospital discharge | Number of patients who died within 30 days of discharge, obtained from chart review. |
| Need for ICU Admission | 1 month after hospital discharge | Will be obtained from chart review after discharge |
| Number of Patients With a 30-day Rib-specific Admission | 1 month after hospital discharge | Patients with at least one rib-specific readmission (delayed hemothorax, pneumothorax, pneumonia, pain) within 30 days of discharge |
| The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Sub Scores | Collected 1, 3, 12 months (post 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 during follow up. Using these questionnaires, McGill Present Pain Intensity (PPI), Sensory, Affective, and Visual Analogue Scale (VAS) sub 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. For all McGill pain scores, a higher score indicates a worse outcome. |
| The Glasgow Outcome Scale Extended (GOS-E) Score | Collected 1, 3, 12 months post 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 during follow up. |
| Short Form (SF-12) Health Survey Scale Summary Scores | Collected 1, 3, 12 months (post 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 during follow up. The composite score is split into two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Both PCS and MCS are standardized scores on a 0-100 scale based on the US population, with a mean of 50 and a standard deviation of 10. Higher PCS or MCS scores indicate better health, while lower scores indicate worse health. |
| Length of Hospital Stay | Up to 1 month from ED arrival | The length of hospital stay will be obtained from the patient's chart after discharge. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoseph D Forrester, MD
Stanford University
PRINCIPAL_INVESTIGATORAriel Knight, MD
Stanford University
Participant flow
Recruitment details
Patients were pre-screened by research staff to determine if the inclusion criteria were met and then discussed with investigators. If investigators approved them, they were approached by research staff for in-person consent at Stanford Healthcare (SHC).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 53 years |
| Daily opioid equivalents before intervention | 42.63 MME/day |
| Highest pain score in first 24 hours | 8.26 score on a scale STANDARD_DEVIATION 1.28 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 1 / 21 |
| other Total, other adverse events | 5 / 19 | 7 / 21 |
| serious Total, serious adverse events | 4 / 19 | 5 / 21 |
Outcome results
None listed