Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis

Not Applicable

Recruiting

• Conditions: Rib Fractures
• Interventions: Device: Cryoneurolysis of Intercostal Nerves; Other: Standard of Care

• Registration Number: NCT05330611
• Lead Sponsor: Stanford University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-15
• Study Start: 2023-02-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound-guided Cryoneurolysis: Group A	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 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	Standard of Care	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.

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	Up to 1 month	The length of hospital stay will be obtained from the patient's chart after discharge.
Daily Numeric Pain Score	12 months	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 Narcotic Equivalents	12 Months	Morphine Milligram Equivalents (MME)

Secondary Outcome Measures

Name	Time	Method
Need for ICU admission	1 month	Will be obtained from chart review after discharge
30-day rib-specific admission	1 month	Incidence of rib-specific readmission (delayed hemothorax, pneumothorax, pneumonia, pain)
Short Form (SF-12) Health Survey Scale Score	30 days, 90 days, 365 days	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.; Score ranges from 1 (Excellent) to 5 (Poor) , 1 (Yes, limited a lot) to 3 (No, not limited at all), 1 (Yes) 2 (No), 1 (Not at all) to 5 (Extremely), 1 (All of the time) to 6 (None of the time) and 1 (All of the time) to 5 (None of the time).
30-day mortality	1 month	Will be obtained from chart review after discharge
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score	30 days, 90 days, 365 days	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. The scoring system yields a pain rating index (PRI) score between 0 and 50 used to temporally track pain, higher scores correspond to higher pain levels.
The Glasgow Outcome Scale Extended (GOS-E) Score	30 days, 90 days, 365 days	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.

Trial Locations

Locations (1)

Stanford Hospital and Clinics; 🇺🇸 Palo Alto, California, United States