[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505741":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":58,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":87,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Sunnybrook Health Sciences Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cryoneurolysis Group","EXPERIMENTAL","In addition to all standard of care analgesia treatments, CN will be performed on the ICN of each broken rib using the Iovera CN device and Generation 2 Iovera tip under ultrasound guidance.",[13],"Procedure: Cryoneurolysis",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care Group","SHAM_COMPARATOR","Participants in the control group will receive all standard of care analgesia treatments as well as sham CN (i.e., application of device without skin puncture or activation of unit) to maintain participant blinding.",[19],"Procedure: Sham Cryoneurolysis",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Cryoneurolysis","Cryoneurolysis will be performed on the intercostal nerve associated with each fractured rib using a handheld cryoneurolysis machine (Iovera). Cryoneurolysis will consist of two 103 second cycles (includes cooling, ice ball formation and warming time) per rib fracture level. Ultrasound guidance will be used to identify appropriate rib fracture levels and to target the device tip in real time. All participants will also receive standard multimodal analgesia and ESP catheter infusion.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham Cryoneurolysis","Participants in the control group will receive sham CN (i.e., application of device without skin puncture or activation of unit) to maintain participant blinding. All participants will also receive standard multimodal analgesia and ESP catheter infusion.",[15],[32],{"name":33,"affiliation":5,"role":34},"Ben Safa, MD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","416-480-4864","ben.safa@sunnybrook.ca",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Toronto","Ontario","M4N3M5","Canada","CA",{"type":49,"coordinates":50},"Point",[51,52],-79.39864,43.70643,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":57,"phoneExt":26,"email":39},"Ben Safa","416 480 4864",{"type":59,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100505741","ultrasound-guided-percutaneous-intercostal-nerve-cryoneurolysis-for-analgesia-following-traumatic-rib-fracture-100505741",false,"NCT05865327","UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture","UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture, a Pilot Randomized Control Trial (UNPIN Trial)","UNPIN","Inclusion Criteria:\n\n* Aged ≥18\n* Unilateral traumatic rib fractures (3 to 8)\n* Candidate for ESP block catheter\n* Within 48hrs of admission to hospital\n\nExclusion Criteria:\n\n* Lack of patient consent; unlikely to comply with follow up\n* Unable to use Patient Controlled Regional Analgesia (Ventilated\u002Fsedated patients or Moderate to severe traumatic brain injury)\n* Chronic pain (opioid use \\> 30mg oral morphine equivalent per day)\n* Substance use disorder\n* CrCl \\\u003C 50\n* BMI \\> 45\n* 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))\n* Contraindications for ESP catheter placement (pre-existing medical\u002Fneurological\u002Fhematologic diseases, localized infection\u002Ftrauma at site of intervention, allergy to amide local anesthetics)\n* Contraindications to CN (cryoglobulinemia, paroxysmal cold hemoglobinuria, multiple myeloma and cold urticarial).\n* Unable to return to Trauma Recovery Clinic (in-person or virtual) at 3 months","ALL","18 Years","100 Years",{"count":72,"type":73},24,"ESTIMATED","INTERVENTIONAL",[76],"NA","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.\n\nA 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 pain medications that they take for 3 months after their pain procedure.",[79,80,81,82,83,84,85,86],"Rib Fractures","Rib Fracture Multiple","Rib; Fracture, With Flail Chest","Pain","Pain, Acute","Pain, Chronic","Trauma","Trauma Injury",[23,88,89],"Rib Fracture Pain","Intercostal Nerve Block","2025-09-05",{"date":92,"type":93},"2025-09-12","ACTUAL",{"date":95,"type":93},"2023-10-23",{"date":97,"type":73},"2025-12",{"name":5,"class":6},1]