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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound-guided Cryoneurolysis: Group A | Experimental | 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 |
|
| Standard-of-Care : Group B | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoneurolysis of Intercostal Nerves | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At time of discharge from hospital (up to 1 month) |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Narcotic Equivalents | Morphine Milligram Equivalents (MME) | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph D Forrester, MD | Stanford University | Principal Investigator |
| Ariel Knight, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Hospital and Clinics | Palo Alto | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7996614 | Background | Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018. | |
| 16269301 | Background | Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022. |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Cryoneurolysis 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. |
| FG001 | 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. Standard 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| 1-month follow-up |
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| 3-month follow-up |
| |||||||||||||||||||
| 12-month follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | At time of discharge from hospital (up to 1 month) |
|
From inpatient enrollment in trial until the end of follow-up, 12 months later
Prospective and retrospective
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Standard 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Readmission for Polytrauma Injury Follow Up | General disorders | Systematic Assessment | Readmissions for polytrauma follow-up unrelated to study intervention |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia and atrial fibrillation | Cardiac disorders | Systematic Assessment | Unrelated to receiving intervention. Occurred during trauma hospitalization. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Forrester | Stanford University | 720-284-2317 | jdf1@stanford.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 31, 2024 | Feb 27, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 20, 2023 | Feb 27, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012253 | Rib Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D013898 | Thoracic Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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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.
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|
| Standard of Care | Other | 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. |
|
| 1 month after hospital discharge |
| Need for ICU Admission | Will be obtained from chart review after discharge | 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 | 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. | 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:
The questionnaire will be administered to the patient by study/clinical staff during follow up. | 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. | 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. | Up to 1 month from ED arrival |
| 18453294 | Background | Sharma OP, Oswanski MF, Jolly S, Lauer SK, Dressel R, Stombaugh HA. Perils of rib fractures. Am Surg. 2008 Apr;74(4):310-4. doi: 10.1177/000313480807400406. |
| 25069400 | Background | Marasco S, Lee G, Summerhayes R, Fitzgerald M, Bailey M. Quality of life after major trauma with multiple rib fractures. Injury. 2015 Jan;46(1):61-5. doi: 10.1016/j.injury.2014.06.014. Epub 2014 Jun 21. |
| 23592156 | Background | Fabricant L, Ham B, Mullins R, Mayberry J. Prolonged pain and disability are common after rib fractures. Am J Surg. 2013 May;205(5):511-5; discusssion 515-6. doi: 10.1016/j.amjsurg.2012.12.007. |
| 24612969 | Background | Gordy S, Fabricant L, Ham B, Mullins R, Mayberry J. The contribution of rib fractures to chronic pain and disability. Am J Surg. 2014 May;207(5):659-62; discussion 662-3. doi: 10.1016/j.amjsurg.2013.12.012. Epub 2014 Jan 31. |
| 12614809 | Background | Liman ST, Kuzucu A, Tastepe AI, Ulasan GN, Topcu S. Chest injury due to blunt trauma. Eur J Cardiothorac Surg. 2003 Mar;23(3):374-8. doi: 10.1016/s1010-7940(02)00813-8. |
| 29766081 | Background | Witt CE, Bulger EM. Comprehensive approach to the management of the patient with multiple rib fractures: a review and introduction of a bundled rib fracture management protocol. Trauma Surg Acute Care Open. 2017 Jan 5;2(1):e000064. doi: 10.1136/tsaco-2016-000064. eCollection 2017. |
| 17161098 | Background | Todd SR, McNally MM, Holcomb JB, Kozar RA, Kao LS, Gonzalez EA, Cocanour CS, Vercruysse GA, Lygas MH, Brasseaux BK, Moore FA. A multidisciplinary clinical pathway decreases rib fracture-associated infectious morbidity and mortality in high-risk trauma patients. Am J Surg. 2006 Dec;192(6):806-11. doi: 10.1016/j.amjsurg.2006.08.048. |
| 24782038 | Background | de Jong MB, Kokke MC, Hietbrink F, Leenen LP. Surgical Management of Rib Fractures: Strategies and Literature Review. Scand J Surg. 2014 Jun;103(2):120-125. doi: 10.1177/1457496914531928. Epub 2014 Apr 29. |
| 29766084 | Background | Shi HH, Esquivel M, Staudenmayer KL, Spain DA. Effects of mechanism of injury and patient age on outcomes in geriatric rib fracture patients. Trauma Surg Acute Care Open. 2017 Mar 16;2(1):e000074. doi: 10.1136/tsaco-2016-000074. eCollection 2017. |
| 32215632 | Background | Tignanelli CJ, Rix A, Napolitano LM, Hemmila MR, Ma S, Kummerfeld E. Association Between Adherence to Evidence-Based Practices for Treatment of Patients With Traumatic Rib Fractures and Mortality Rates Among US Trauma Centers. JAMA Netw Open. 2020 Mar 2;3(3):e201316. doi: 10.1001/jamanetworkopen.2020.1316. |
| 27912931 | Background | Pieracci FM, Majercik S, Ali-Osman F, Ang D, Doben A, Edwards JG, French B, Gasparri M, Marasco S, Minshall C, Sarani B, Tisol W, VanBoerum DH, White TW. Consensus statement: Surgical stabilization of rib fractures rib fracture colloquium clinical practice guidelines. Injury. 2017 Feb;48(2):307-321. doi: 10.1016/j.injury.2016.11.026. Epub 2016 Nov 27. No abstract available. |
| 32176172 | Background | Chen Zhu R, de Roulet A, Ogami T, Khariton K. Rib fixation in geriatric trauma: Mortality benefits for the most vulnerable patients. J Trauma Acute Care Surg. 2020 Jul;89(1):103-110. doi: 10.1097/TA.0000000000002666. |
| 23169127 | Background | Ryb GE, Dischinger PC, Burch CA, Kerns TJ, Kufera J, Andersen D. Frailty and injury causation. Ann Adv Automot Med. 2012;56:175-81. |
| 27533913 | Background | Galvagno SM Jr, Smith CE, Varon AJ, Hasenboehler EA, Sultan S, Shaefer G, To KB, Fox AD, Alley DE, Ditillo M, Joseph BA, Robinson BR, Haut ER. Pain management for blunt thoracic trauma: A joint practice management guideline from the Eastern Association for the Surgery of Trauma and Trauma Anesthesiology Society. J Trauma Acute Care Surg. 2016 Nov;81(5):936-951. doi: 10.1097/TA.0000000000001209. |
| 27749354 | Background | Ilfeld BM. Continuous Peripheral Nerve Blocks: An Update of the Published Evidence and Comparison With Novel, Alternative Analgesic Modalities. Anesth Analg. 2017 Jan;124(1):308-335. doi: 10.1213/ANE.0000000000001581. |
| 27745867 | Background | Keller BA, Kabagambe SK, Becker JC, Chen YJ, Goodman LF, Clark-Wronski JM, Furukawa K, Stark RA, Rahm AL, Hirose S, Raff GW. Intercostal nerve cryoablation versus thoracic epidural catheters for postoperative analgesia following pectus excavatum repair: Preliminary outcomes in twenty-six cryoablation patients. J Pediatr Surg. 2016 Dec;51(12):2033-2038. doi: 10.1016/j.jpedsurg.2016.09.034. Epub 2016 Sep 28. |
| 30278932 | Background | Harbaugh CM, Johnson KN, Kein CE, Jarboe MD, Hirschl RB, Geiger JD, Gadepalli SK. Comparing outcomes with thoracic epidural and intercostal nerve cryoablation after Nuss procedure. J Surg Res. 2018 Nov;231:217-223. doi: 10.1016/j.jss.2018.05.048. Epub 2018 Jun 21. |
| 31388539 | Background | Vossler JD, Zhao FZ. Intercostal nerve cryoablation for control of traumatic rib fracture pain: A case report. Trauma Case Rep. 2019 Jul 31;23:100229. doi: 10.1016/j.tcr.2019.100229. eCollection 2019 Oct. |
| 23954965 | Background | Koethe Y, Mannes AJ, Wood BJ. Image-guided nerve cryoablation for post-thoracotomy pain syndrome. Cardiovasc Intervent Radiol. 2014 Jun;37(3):843-6. doi: 10.1007/s00270-013-0718-8. Epub 2013 Aug 17. |
| 17000825 | Background | Byas-Smith MG, Gulati A. Ultrasound-guided intercostal nerve cryoablation. Anesth Analg. 2006 Oct;103(4):1033-5. doi: 10.1213/01.ane.0000237290.68166.c2. |
| 31804414 | Background | Pieracci FM, Leasia K, Bauman Z, Eriksson EA, Lottenberg L, Majercik S, Powell L, Sarani B, Semon G, Thomas B, Zhao F, Dyke C, Doben AR. A multicenter, prospective, controlled clinical trial of surgical stabilization of rib fractures in patients with severe, nonflail fracture patterns (Chest Wall Injury Society NONFLAIL). J Trauma Acute Care Surg. 2020 Feb;88(2):249-257. doi: 10.1097/TA.0000000000002559. |
| 1235985 | Background | Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-299. doi: 10.1016/0304-3959(75)90044-5. |
| 30442372 | Background | Marasco SF, Martin K, Niggemeyer L, Summerhayes R, Fitzgerald M, Bailey M. Impact of rib fixation on quality of life after major trauma with multiple rib fractures. Injury. 2019 Jan;50(1):119-124. doi: 10.1016/j.injury.2018.11.005. Epub 2018 Nov 3. |
| 9726257 | Background | Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998 Aug;15(8):573-85. doi: 10.1089/neu.1998.15.573. |
| 8628042 | Background | Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003. |
| 41604277 | Derived | Forrester JD, Tung JT, Knight AW, Wang S, Myers AA, King JM, Earley MJ, Guthrie-Baker S, Flojo RB, Chen JT, Abreo AM; Stanford, California. Chilling the nerve, easing the pain?: A randomized clinical trial evaluating surgeon-administered bedside percutaneous cryoneurolysis for rib fracture pain. J Trauma Acute Care Surg. 2026 Jun 1;100(6):863-870. doi: 10.1097/TA.0000000000004885. Epub 2026 May 22. |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Highest pain score in first 24 hours | This is the initial baseline pain measurement taken within the first 24 hours of hospital stay and is on a scale of 0 (no pain) to 10 (maximum pain). | Mean | Standard Deviation | score on a scale |
|
| Daily opioid equivalents before intervention | This is the initial baseline MME intake measurement taken before intervention, measured in morphine milligram equivalents (MMEs). If hours to intervention (intervention patients) or hours to consent (SOC) were less than 24 hours, this measurement was standardized to 24 hours. | Median | Inter-Quartile Range | MME/day |
|
| OG001 | 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. Standard 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. |
|
|
|
| Secondary | Daily Narcotic Equivalents | Morphine Milligram Equivalents (MME) | Participants with MME values recorded in their charts at each time point were analyzed. | Posted | Median | Inter-Quartile Range | MME/day | Collected at discharge (up to 1 month), 1, 3, 12 months post discharge |
|
|
|
|
| Secondary | Number of Patients With 30-day Mortality | Number of patients who died within 30 days of discharge, obtained from chart review. | All participants with available data were analyzed. | Posted | Count of Participants | Participants | 1 month after hospital discharge |
|
|
|
|
| Secondary | Need for ICU Admission | Will be obtained from chart review after discharge | Posted | Count of Participants | Participants | 1 month after hospital discharge |
|
|
|
|
| Secondary | 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 | Participants with available data were analyzed. | Posted | Count of Participants | Participants | 1 month after hospital discharge |
|
|
|
|
| Secondary | 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. | The analysis population includes everyone who has at least 1 McGill score reported at any follow-up timepoint. Since follow-up was conducted by phone and the McGill visual analogue scale requires an in-person assessment, no patients had a visual analogue score. | Posted | Mean | Standard Deviation | scores on a scale | Collected 1, 3, 12 months (post hospital discharge) |
|
|
|
|
| Secondary | 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:
The questionnaire will be administered to the patient by study/clinical staff during follow up. | Participants who had GOS-E data at any follow-up time point are included. Deaths were not included. | Posted | Count of Participants | Participants | Collected 1, 3, 12 months post hospital discharge |
|
|
|
|
| Secondary | 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. | Participants with available SF-12 scores at any follow-up time point were included. | Posted | Median | Inter-Quartile Range | scores on a scale | Collected 1, 3, 12 months (post hospital discharge) |
|
|
|
|
| Secondary | Length of Hospital Stay | The length of hospital stay will be obtained from the patient's chart after discharge. | Posted | Median | Inter-Quartile Range | days | Up to 1 month from ED arrival |
|
|
|
|
| 0 |
| 19 |
| 4 |
| 19 |
| 5 |
| 19 |
| EG001 | 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 Cryoneurolysis 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. | 1 | 21 | 5 | 21 | 7 | 21 |
|
| Chest Wall Related Readmission | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Worsening pneumo/hemothorax or pleural effusion requiring medical intervention |
|
|
| Pulmonary Adverse Events | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Includes worsening pneumothorax, pulmonary embolism, new pleural effusion, hemothorax, hypoxia or the need for supplemental Oxygen. |
|
| Gastrointestinal AEs | Gastrointestinal disorders | Systematic Assessment | Constipation, reflux, nausea, vertigo |
|
Not provided
Not provided
| 1-month follow-up |
|
|
| 3-month follow-up |
|
|
| 12-month follow-up |
|
|
| 0.201 |
The statistical significance level was 0.05. |
| Superiority |
| MMEs at 3-month follow-up | Wilcoxon (Mann-Whitney) | 0.715 | The statistical significance level was 0.05. | Superiority |
| MMEs at 12-month follow-up | Wilcoxon (Mann-Whitney) | >0.99 | The statistical significance level was 0.05. | Superiority |
| Sensory at 1-month follow-up |
|
|
| Affective at 1-month follow-up |
|
|
| Visual Analogue Scale at 1-month follow-up |
|
| PPI at 3-month follow-up |
|
|
| Sensory at 3-month follow-up |
|
|
| Affective at 3-month follow-up |
|
|
| Visual Analogue Scale at 3-month follow-up |
|
| PPI at 12-month follow-up |
|
|
| Sensory at 12-month follow-up |
|
|
| Affective at 12-month follow-up |
|
|
| Visual Analogue Scale at 12-month follow-up |
|
| t-test, 2 sided |
Pooled t-test |
| 0.277 |
The two-sided statistical significance level was 0.05. |
| Superiority |
| McGill Affective at 1-month follow-up | Wilcoxon (Mann-Whitney) | 0.178 | The statistical significance level was 0.05. | Superiority |
| McGill PPI at 3-month follow-up | t-test, 2 sided | Pooled t-test | 0.209 | The two-sided statistical significance level was 0.05. | Superiority |
| McGill Sensory at 3-month follow-up | t-test, 2 sided | Sattherwaite t-test | 0.218 | The two-sided statistical significance level was 0.05. | Superiority |
| McGill Affective at 3-month follow-up | Wilcoxon (Mann-Whitney) | 0.396 | The statistical significance level was 0.05. | Superiority |
| McGill PPI at 12-month follow-up | t-test, 2 sided | Pooled t-test | > 0.99 | The two-sided statistical significance level was 0.05. | Superiority |
| McGill Sensory at 12-month follow-up | Wilcoxon (Mann-Whitney) | Pooled t-test | 0.512 | The two-sided statistical significance level was 0.05. | Superiority |
| McGill Affective at 12-month follow--up | Wilcoxon (Mann-Whitney) | 0.374 | The statistical significance level was 0.05. | Superiority |
| This analysis assessed if pain scores decreased from discharge to 1-month follow-up among intervention patients | Wilcoxon signed-rank | This analysis only included the 16 intervention participants with valid pain scores at discharge and 1-month follow-up. | <0.001 | The statistical significance level was 0.05. | Other | This test did not compare between groups. |
| This analysis assessed if pain scores decreased from 1-month follow-up to 3-month follow-up among intervention participants. | Wilcoxon (signed-rank) | This analysis only included the 14 participants who had a PPI score at 1-month and 3-month follow-up. | 0.191 | The significance level was 0.05. | Other | This test did not compare between groups. |
| This analysis assessed whether McGill PPI scores decreased from 3-month to 12-month follow-up among intervention participants. | Wilcoxon (signed-rank) | This analysis only included the 8 patients who had PPI scores at 3-month and 12-month follow-ups. | 0.125 | The statistical significance level was 0.05. | Other | This test did not compare between groups. |
| The model assessed differential change in pain score over time. It included pain scores reported at baseline and discharge, as well as PPI scores reported at all three follow-ups. | Mixed Models Analysis | 0.578 | The two-sided statistical significance level was 0.05. The reported p-value was for the interaction between time and treatment group. The model was a random intercept and slope (RIAS) model. | Superiority |
| MD- |
|
| MD+ |
|
| GR- |
|
| GR+ |
|
| 3-month follow-up |
|
|
| 12-month follow-up |
|
|
| 0.456 |
The statistical significance level was 0.05. |
| Superiority |
| GOS-E at 12-month follow-up | Freeman-Halton | >0.99 | The statistical significance level was 0.05. | Superiority |
| SF-12 MCS at 1-month follow-up |
|
|
| SF-12 PCS at 3-month follow-up |
|
|
| SF-12 MCS at 3-month follow-up |
|
|
| SF-12 PCS at 12-month follow-up |
|
|
| SF-12 MCS at 12-month follow-up |
|
|
| Wilcoxon (Mann-Whitney) |
| 0.921 |
The two-sided statistical significance level was 0.05. |
| Superiority |
| SF-12 PCS at 3-month follow-up | Wilcoxon (Mann-Whitney) | 0.117 | The statistical significance level was 0.05. | Superiority |
| SF-12 MCS at 3-month follow-up | Wilcoxon (Mann-Whitney) | 0.292 | The statistical significance level was 0.05. | Superiority |
| SF-12 PCS at 12-month follow-up | Wilcoxon (Mann-Whitney) | 0.860 | The statistical significance level was 0.05. | Superiority |
| SF-12 MCS at 12-month follow-up | Wilcoxon (Mann-Whitney) | 0.077 | The statistical significance level was 0.05. | Superiority |