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Completed

NCT Number: NCT04482582

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

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

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Key information

Conditions

Rib Fractures Fractures, Bone Thoracic Injuries Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Hospital and Clinics

Palo Alto, California, 94305, United States

About this study

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. In order to do this, we would offer a minimally invasive solution known as Cryoneurolysis. By directly applying cold Cryoneurolysis to the nerves, this can destroy nerve axons, resulting in Wallerian degeneration of the distal nerve without distorting epineural or perineurial tissue. The application of cryoneurolysis will help reduce the amount of narcotics the patient would need, and potentially lead to a better post-injury quality of life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

i) Patients greater than 65 years with any acute rib fracture

ii) Pain score equal to or greater than 5 with deep inspiration.

iii) Presenting and admitted to Stanford Emergency Department

Exclusion criteria

i) Radiographic evidence of metastasis to ribs

ii) Glasgow Coma Scale (GCS) score <13

iii) Patients undergoing SSRF

iv) Rib fractures located < 3cm from spinous process

v) Coagulopathy (INR >1.5, Pat < 100)

vi) Other factors precluding cryoablation at IR attending's discretion

vii) If only ribs broken are 1,2 or 10,11, 12

Treatment and study plan

Cryoneurolysis

Radiation

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.

Standard of care

Other

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.

Primary outcomes

  1. Acute Pain Assessed by Numeric Pain Score

    Time frame: Hospital discharge (up to 1 month)

    The patient will be asked to verbalize their numeric pain score on the day of hospital discharge. Pain is measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain.

    Note: The timing of hospital discharge varies by patient as these are polytrauma patients.

Secondary outcomes

  1. 30-day Mortality

    Time frame: 1 month after hospital discharge

    Will be obtained from chart review after discharge

  2. Number of Participants Requiring ICU Admission

    Time frame: 1 month after hospital discharge

    Will be obtained from chart review after discharge

  3. 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.

  4. Use of Narcotic Equivalents

    Time frame: Hospital discharge (up to 1 month), 1 month, 3 months, 12 months after hospital discharge

    Daily oral narcotic equivalents

  5. Number of Participants With a Rib-specific Readmission Within 30 Days of Discharge

    Time frame: 1 month after hospital discharge

    The patient will be admitted back to the hospital if pain level relates to rib-specific injuries such as hemothorax and pneumonia.

  6. The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score

    Time frame: 1 month, 3 months, 12 months (all from hospital discharge)

    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 at 1-month, 3-month, and 12-month follow-ups. Using the questionnaires, McGill Present Pain Intensity (PPI), Sensory, Affective, and Visual Analogue Scale 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. Higher scores indicate worse pain for all McGill scores.

  7. The Glasgow Outcome Scale Extended (GOS-E) Score

    Time frame: 1 month, 3 months, 12 months (all from hospital discharge)

    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.

  8. Short Form (SF-12) Health Survey Scale Score

    Time frame: 1 month, 3 months, 12 months (all from hospital discharge)

    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. The composite score is split into two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Both scores are on a scale of 0-100, with higher scores representing better mental health-related (MCS) or physical health-related (PCS) quality of life. The means of both scores are standardized to 50 with a standard devation of 10.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: EPERC

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jul 22, 2020
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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