Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis (Trauma-PC2)

Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis for Pain Control (Trauma-PC2-study)

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.

Study Overview

• Status: Completed
• Conditions: Rib Fractures
• Intervention / Treatment: Other: Standard of Care; Device: Cryoneurolysis of Intercostal Nerves

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Narcotic Equivalents	Morphine Milligram Equivalents (MME)	Collected at discharge (up to 1 month), 1, 3, 12 months post 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: 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 during follow up.	Collected 1, 3, 12 months post hospital discharge
Number of Patients With 30-day Mortality	Number of patients who died within 30 days of discharge, obtained from chart review.	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)
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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Joseph D Forrester, MD, Stanford University; Principal Investigator: Ariel Knight, MD, Stanford University

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Actual): February 2, 2025
• Study Completion (Actual): February 2, 2026

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Percutaneous Cryoneurolysis
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Thoracic Injuries; Rib Fractures; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 64713

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No