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Early Percutaneous Cryoablation for Pain Control After Rib Fractures Among Elderly Patients

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ClinicalTrials.gov Identifier: NCT04482582
Recruitment Status : Not yet recruiting
First Posted : July 22, 2020
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Joseph Forrester, Stanford University

Study Description
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Brief Summary:
The purpose of this study is to provide long-term pain control for elderly patients with rib fractures in order to minimize their risk of complications and return them to baseline functional capacity

Condition or disease Intervention/treatment Phase
Rib Fractures Radiation: Cryoneurolysis Other: Standard of Care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We are proposing a prospective, randomized trial evaluating efficacy of image-guided percutaneous intercostal cryoneurolysis (pICN) for pain control after traumatic rib fractures in persons >=65 years. Eligible patients would be enrolled by the trauma service after consent or assent is obtained. Patients will be randomized to either pICN within 72 hours of presentation or existing standard-of-care.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Percutaneous Cryoablation for Pain Control After Rib Fractures Among Elderly Patients
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 31, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Image-guided percutaneous ICN (pICN): Group A
Patients who were admitted after a traumatic injury, with rib fractures identified, who are >= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.
 Radiation: Cryoneurolysis
Patients will be offered a minimally invasive solution known as cryoneurolysis. By directly applying a cold cryoneurolysis probe to the nerves the axon is destroyed, resulting in Wallerian degeneration of the distal nerve without distorting epineurial or perineurial tissue. Application of cryoneurolysis will help reduce the amount of narcotics the patient would need to take and instead provide them longer term pain control with minimal risk.
Active Comparator: Standard-of Care : Group B
Patients who were admitted after a traumatic injury, with rib fractures identified, who are >= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.
 Other: Standard of Care
Patients will be provided regular standard of care at the Stanford Hospital with long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.


Outcome Measures
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Primary Outcome Measures :
  1. Acute Pain Assessed by Numeric Pain Score [ Time Frame: 12 months ]
    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.

  2. Length of hospital stay [ Time Frame: Up to 1 month ]
    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 :
  1. 30-day mortality [ Time Frame: 1 month ]
    Will be obtained from chart review after discharge

  2. Number of participants requiring ICU admission [ Time Frame: 1 month ]
    Will be obtained from chart review after discharge

  3. Use of Narcotic Equivalents [ Time Frame: 12 months ]
    Oral narcotic equivalents on day of discharge.

  4. 30-day rib-specific readmission [ Time Frame: 1 month ]
    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.

  5. The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score [ Time Frame: 12 months ]
    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.

  6. The Glasgow Outcome Scale Extended (GOS-E) Score [ Time Frame: 12 months ]

    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 upon discharge.


  7. Short Form (SF-12) Health Survey Scale Score [ Time Frame: 12 months ]

    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).



Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Patients greater than 65 years with any acute rib fracture of ribs 3,4,5,6,7,8, or 9.
  • Pain score higher than or equal to 3
  • Presenting and admitted to Stanford Emergency Department

Exclusion:

  • Radiographic evidence of metastasis to ribs
  • Glasgow Coma Scale (GCS) score < 13
  • Patients undergoing Surgical Stabilization of Rib Fractures (SSRF)
  • Rib fractures located < 3cm from spinous process
  • Coagulopathy (INR >1.5, Pat < 100)
  • Other factors precluding cryoablation at Interventional Radiologist (IR) attending's discretion
  • Patients who do not have any rib fractures of ribs 3,4,5,6,7,8, or 9.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04482582


Contacts
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Contact: Sharon Cardenas-Ledezma, BS (650) 724-4023 carshar@stanford.edu

Locations
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United States, California
Stanford Hospital and Clinics
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Joseph D Forrester, MD Stanford University
More Information
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Publications:

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Responsible Party: Joseph Forrester, Assistant Professor of Surgery, Stanford University
ClinicalTrials.gov Identifier: NCT04482582    
Other Study ID Numbers: 57099
First Posted: July 22, 2020    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Fractures, Bone
Rib Fractures
Wounds and Injuries
Thoracic Injuries