An interventional study of Cryoneurolysis of Intercostal Nerves and Standard of Care in Rib Fractures, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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.
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.
131 studies on the registry are indexed under Rib Fractures; 27 are open to participants now.
This study's enrollment of 43 is below the median of 60 across 99 interventional studies indexed under Rib Fractures.
Browse Rib Fractures studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Device: Cryoneurolysis of Intercostal Nerves
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.
Other: Standard of Care
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.
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.
Daily Numeric Pain Score
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.
Time frame: At time of discharge from hospital (up to 1 month)
Daily Narcotic Equivalents
Morphine Milligram Equivalents (MME)
Time frame: Collected at discharge (up to 1 month), 1, 3, 12 months post discharge
Number of Patients With 30-day Mortality
Number of patients who died within 30 days of discharge, obtained from chart review.
Time frame: 1 month after hospital discharge
Need for ICU Admission
Will be obtained from chart review after discharge
Time frame: 1 month after hospital discharge
Number of Patients With a 30-day Rib-specific Admission
Patients with at least one rib-specific readmission (delayed hemothorax, pneumothorax, pneumonia, pain) within 30 days of discharge
Time frame: 1 month after hospital discharge
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Sub Scores
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.
Time frame: Collected 1, 3, 12 months (post hospital discharge)
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: 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.
Time frame: Collected 1, 3, 12 months post hospital discharge
Short Form (SF-12) Health Survey Scale Summary Scores
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.
Time frame: Collected 1, 3, 12 months (post hospital discharge)
Length of Hospital Stay
The length of hospital stay will be obtained from the patient's chart after discharge.
Time frame: Up to 1 month from ED arrival
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).
| Milestone | Ultrasound-guided Cryoneurolysis: Group A | Standard-of-Care : Group B |
|---|---|---|
| Started | 24 | 19 |
| Completed | 21 | 19 |
| Not completed | 3 | 0 |
| Withdrew: Screen failure | 3 | 0 |
| Milestone | Ultrasound-guided Cryoneurolysis: Group A | Standard-of-Care : Group B |
|---|---|---|
| Started | 21 | 19 |
| Completed | 16 | 15 |
| Not completed | 5 | 4 |
| Withdrew: Lost to follow-up | 5 | 3 |
| Withdrew: Incarcerated | 0 | 1 |
| Milestone | Ultrasound-guided Cryoneurolysis: Group A | Standard-of-Care : Group B |
|---|---|---|
| Started | 21 | 18 |
| Completed | 14 | 12 |
| Not completed | 7 | 6 |
| Withdrew: Lost to follow-up | 7 | 6 |
| Milestone | Ultrasound-guided Cryoneurolysis: Group A | Standard-of-Care : Group B |
|---|---|---|
| Started | 21 | 18 |
| Completed | 9 | 9 |
| Not completed | 12 | 9 |
| Withdrew: Incarcerated | 1 | 0 |
| Withdrew: Lost to follow-up | 10 | 9 |
| Withdrew: Death | 1 | 0 |
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.
| score on a scale | Ultrasound-guided Cryoneurolysis: Group A | Standard-of-Care : Group B |
|---|---|---|
| Daily Numeric Pain Score | 7.48 ± 2.11 | 6.47 ± 2.97 |
Morphine Milligram Equivalents (MME)
| MME/day | Ultrasound-guided Cryoneurolysis: Group A | Standard-of-Care : Group B |
|---|---|---|
| Discharge | 60 (15.65 to 94.50) | 15 (0 to 60) |
| 1-month follow-up | 0 (0 to 10) | 0 (0 to 0) |
| 3-month follow-up | 0 (0 to 0) | 0 (0 to 0) |
| 12-month follow-up | 0 (0 to 0) | 0 (0 to 0) |
Number of patients who died within 30 days of discharge, obtained from chart review.
| Participants | Ultrasound-guided Cryoneurolysis: Group A | Standard-of-Care : Group B |
|---|---|---|
| Number of Patients With 30-day Mortality | 0 | 0 |
Will be obtained from chart review after discharge
| Participants | Ultrasound-guided Cryoneurolysis: Group A | Standard-of-Care : Group B |
|---|---|---|
| Need for ICU Admission | 3 | 0 |
Patients with at least one rib-specific readmission (delayed hemothorax, pneumothorax, pneumonia, pain) within 30 days of discharge
| Participants | Ultrasound-guided Cryoneurolysis: Group A | Standard-of-Care : Group B |
|---|---|---|
| Number of Patients With a 30-day Rib-specific Admission | 0 | 0 |
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.
| scores on a scale | Ultrasound-guided Cryoneurolysis: Group A | Standard-of-Care : Group B |
|---|---|---|
| PPI at 1-month follow-up | 3.19 ± 2.69 | 2.07 ± 2.25 |
| Sensory at 1-month follow-up | 2.19 ± 1.60 | 1.53 ± 1.68 |
| Affective at 1-month follow-up | 0.19 ± 0.54 | 0 ± 0 |
| PPI at 3-month follow-up | 2.07 ± 2.76 | 0.92 ± 1.51 |
| Sensory at 3-month follow-up | 1.64 ± 2.27 | 0.75 ± 1.22 |
| Affective at 3-month follow-up | 0.50 ± 1.87 | 0 ± 0 |
| PPI at 12-month follow-up | 0.67 ± 1.00 | 0.67 ± 1.32 |
| Sensory at 12-month follow-up | 0.56 ± 1.33 | 0.22 ± 0.67 |
| Affective at 12-month follow-up | 0 ± 0 | 0.11 ± 0.33 |
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.
| Participants | Ultrasound-guided Cryoneurolysis: Group A | Standard-of-Care : Group B |
|---|---|---|
| 1-month follow-up — SD- | 1 | 0 |
| 1-month follow-up — MD- | 8 | 5 |
| 1-month follow-up — MD+ | 1 | 2 |
| 1-month follow-up — GR- | 2 | 3 |
| 1-month follow-up — GR+ | 4 | 5 |
| 3-month follow-up — SD- | 0 | 0 |
| 3-month follow-up — MD- | 3 | 2 |
| 3-month follow-up — MD+ | 3 | 0 |
| 3-month follow-up — GR- | 1 | 2 |
| 3-month follow-up — GR+ | 7 | 8 |
| 12-month follow-up — SD- | 0 | 0 |
| 12-month follow-up — MD- | 1 | 2 |
| 12-month follow-up — MD+ | 0 | 0 |
| 12-month follow-up — GR- | 0 | 0 |
| 12-month follow-up — GR+ | 8 | 7 |
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.
| scores on a scale | Ultrasound-guided Cryoneurolysis: Group A | Standard-of-Care : Group B |
|---|---|---|
| SF-12 PCS at 1-month follow-up | 34.28 (23.01 to 42.30) | 32.04 (24.72 to 49.98) |
| SF-12 MCS at 1-month follow-up | 53.60 (48.08 to 57.38) | 51.74 (49.41 to 57.72) |
| SF-12 PCS at 3-month follow-up | 40.89 (28.38 to 54.18) | 54.55 (39.21 to 57.13) |
| SF-12 MCS at 3-month follow-up | 56.01 (47.10 to 59.59) | 51.82 (50.36 to 54.29) |
| SF-12 PCS at 12-month follow-up | 52.77 (40.70 to 55.19) | 53.13 (47.89 to 55.73) |
| SF-12 MCS at 12-month follow-up | 59.26 (52.51 to 61.15) | 53.47 (49.40 to 55.87) |
The length of hospital stay will be obtained from the patient's chart after discharge.
| days | Ultrasound-guided Cryoneurolysis: Group A | Standard-of-Care : Group B |
|---|---|---|
| Length of Hospital Stay | 4 (3 to 7) | 3 (2 to 4) |
Collected over From inpatient enrollment in trial until the end of follow-up, 12 months later. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard-of-Care : Group B | 0/19 (0%) | 4/19 (21.1%) | 5/19 (26.3%) |
| Ultrasound-guided Cryoneurolysis: Group A | 1/21 (4.8%) | 5/21 (23.8%) | 7/21 (33.3%) |
| Event | Standard-of-Care : Group B | Ultrasound-guided Cryoneurolysis: Group A |
|---|---|---|
| Readmission for Polytrauma Injury Follow UpGeneral disorders | 4/19 | 3/21 |
| Chest Wall Related ReadmissionRespiratory, thoracic and mediastinal disorders | 0/19 | 2/21 |
| Event | Standard-of-Care : Group B | Ultrasound-guided Cryoneurolysis: Group A |
|---|---|---|
| Pulmonary Adverse EventsRespiratory, thoracic and mediastinal disorders | 3/19 | 4/21 |
| Tachycardia and atrial fibrillationCardiac disorders | 1/19 | 2/21 |
| Gastrointestinal AEsGastrointestinal disorders | 1/19 | 1/21 |
| Age, Continuous(years) | Ultrasound-guided Cryoneurolysis: Group A | Standard-of-Care : Group B | Total |
|---|---|---|---|
| Median | 53 (49 to 58) | 53 (37 to 60) | 53 (45 to 60) |
| Sex: Female, Male(Participants) | Ultrasound-guided Cryoneurolysis: Group A | Standard-of-Care : Group B | Total |
|---|---|---|---|
| Female | 5 | 4 | 9 |
| Male | 16 | 15 | 31 |
| Race (NIH/OMB)(Participants) | Ultrasound-guided Cryoneurolysis: Group A | Standard-of-Care : Group B | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 3 | 4 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 11 | 12 | 23 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 5 | 2 | 7 |
| Highest pain score in first 24 hours(score on a scale) | Ultrasound-guided Cryoneurolysis: Group A | Standard-of-Care : Group B | Total |
|---|---|---|---|
| Mean | 8.76 ± 1.34 | 8.26 ± 1.28 | 8.53 ± 1.32 |
| Daily opioid equivalents before intervention(MME/day) | Ultrasound-guided Cryoneurolysis: Group A | Standard-of-Care : Group B | Total |
|---|---|---|---|
| Median | 96.5 (42 to 135.43) | 42.63 (26 to 147.50) | 59 (29.5 to 136.36) |
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