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Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis

Primary Purpose

Rib Fractures

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cryoneurolysis of Intercostal Nerves
Standard of Care
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rib Fractures

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients 18 to 64 years with any acute rib fracture
  • Pain score equal to or greater than 5 with deep inspiration.
  • Any acute rib fracture between rib 3 and rib 9
  • Presenting and admitted to Stanford Emergency Department

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, Pat < 100)
  • Other factors precluding cryoablation at IR attending's discretion
  • If only ribs broken are 1,2 or 10,11, 12

Sites / Locations

  • Stanford Hospital and ClinicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasound-guided Cryoneurolysis: Group A

Standard-of-Care : Group B

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Acute Pain Assessed by Numeric Pain Score
The patient will be asked to verbalize their numeric pain score daily after discharge and at follow-up visits. Pain measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain.
Length of hospital stay
The Length of Stay will be obtained from the patient's chart after discharge and will depend on the level of care required for recovery from their injuries.

Secondary Outcome Measures

30-day mortality
Will be obtained from chart review after discharge
Number of participants requiring ICU admission
Will be obtained from chart review after discharge
Use of Narcotic Equivalents
Oral narcotic equivalents on day of discharge
30-day rib-specific admission
Incidence of readmission. The patient will be admitted back to the hospital if pain level relates to rib-specific injuries such as hemothorax and pneumonia.
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
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 upon discharge. 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
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 upon discharge.
Short Form (SF-12) Health Survey Scale Score
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 upon discharge. 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).

Full Information

First Posted
March 11, 2022
Last Updated
April 12, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05330611
Brief Title
Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis
Official Title
Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis for Pain Control (Trauma-PC2-study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound-guided Cryoneurolysis: Group A
Arm Type
Experimental
Arm Description
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
Arm Title
Standard-of-Care : Group B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cryoneurolysis of Intercostal Nerves
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acute Pain Assessed by Numeric Pain Score
Description
The patient will be asked to verbalize their numeric pain score daily after discharge and at follow-up visits. Pain measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain.
Time Frame
12 months
Title
Length of hospital stay
Description
The Length of Stay will be obtained from the patient's chart after discharge and will depend on the level of care required for recovery from their injuries.
Time Frame
Up to 1 month
Secondary Outcome Measure Information:
Title
30-day mortality
Description
Will be obtained from chart review after discharge
Time Frame
1 month
Title
Number of participants requiring ICU admission
Description
Will be obtained from chart review after discharge
Time Frame
1 month
Title
Use of Narcotic Equivalents
Description
Oral narcotic equivalents on day of discharge
Time Frame
12 months
Title
30-day rib-specific admission
Description
Incidence of readmission. The patient will be admitted back to the hospital if pain level relates to rib-specific injuries such as hemothorax and pneumonia.
Time Frame
1 month
Title
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
Description
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 upon discharge. 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.
Time Frame
30 days, 90 days, 365 days
Title
The Glasgow Outcome Scale Extended (GOS-E) Score
Description
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 upon discharge.
Time Frame
30 days, 90 days, 365 days
Title
Short Form (SF-12) Health Survey Scale Score
Description
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 upon discharge. 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).
Time Frame
30 days, 90 days, 365 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 18 to 64 years with any acute rib fracture Pain score equal to or greater than 5 with deep inspiration Any acute rib fracture between rib 3 and rib 9 Presenting and admitted to Stanford Emergency Department 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 cryoablation at IR attending's discretion If only ribs broken are 1,2 or 10,11,12
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Myers, BA
Phone
(650)498-3284
Email
amyers19@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Anisha Abreo, MPH
Phone
(650)723-9288
Email
aabreo@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph D Forrester, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ara Ko, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Hospital and Clinics
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
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Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis

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