UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture
RecruitingNot applicableNCT05865327
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
Brief summary (from the registry)
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 pain medications that they take for 3 months after their pain procedure.
Study details
- Official title
- UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture, a Pilot Randomized Control Trial (UNPIN Trial)
- Conditions
- Rib Fractures
- Rib Fracture Multiple
- Rib
- Fracture, With Flail Chest
- Pain
- Pain, Acute
- Pain, Chronic
- Trauma
- Trauma Injury
- Interventions
- Procedure: Cryoneurolysis
- Procedure: Sham Cryoneurolysis
- Sponsor
- Sunnybrook Health Sciences Centre
- Start date
- 2023-10-23
- Primary completion
- 2025-12
- Sex
- All
- Age range
- from 18 Years to 100 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Canadian sites (1)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05865327