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UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture

RecruitingNAAges 18 Years - 100 YearsAllSunnybrook Health Sciences Centre
NCT05865327 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Traumatic rib fractures (i.e., broken ribs caused by a physical injury) are common and very painful. They also often lead to serious complications, more time spent in hospital, and can even lead to death. Even after rib fractures have healed, they can lead to long-term pain and a lower quality of life. A technology called cryoneurolysis, which acts to freeze nerves causing pain using a small tool which can turn very cold, is a promising new way to manage rib fracture pain. This study is a test with a small number of people to see if it is feasible to use this technology for patients with rib fractures. If this is successful, we will recruit more people for a larger study to see if cryoneurolysis, along with standard pain control techniques, is better at stopping pain, compared to just the normal techniques alone. Participants in our study will be asked to rate their pain, and record pai

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged ≥18 * Unilateral traumatic rib fractures (3 to 8) * Candidate for ESP block catheter * Within 48hrs of admission to hospital Exclusion Criteria: * Lack of patient consent; unlikely to comply with follow up * Unable to use Patient Controlled Regional Analgesia (Ventilated/sedated patients or Moderate to severe traumatic brain injury) * Chronic pain (opioid use \> 30mg oral morphine equivalent per day) * Substance use disorder * CrCl \< 50 * BMI \> 45 * Significant distracting injuries (unreduced long bone fractures, unstable pelvic or spine fractures and patients requiring trauma laparotomy- also preclude positioning for block placement (lateral decubitus or sitting up)) * Contraindications for ESP catheter placement (pre-existing medical/neurological/hematologic diseases, localized infection/trauma at site of intervention, allergy to amide local anesthetics) * Contraindications to CN (cryoglobulinemia, paroxysmal cold hemoglobinuria, multiple myeloma and cold urticarial). * Unable to return to Trauma Recovery Clinic (in-person or virtual) at 3 months
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What it tests

  • Cryoneurolysis
  • Sham Cryoneurolysis
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Where

1 site
Sunnybrook Health Sciences Centre
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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