NCT05865327 UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture
| NCT ID | NCT05865327 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Rib Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-10-23 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2023-10-23 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Ben Safa, MD
PRINCIPAL INVESTIGATOR
Sunnybrook Health Sciences Centre
Frequently Asked Questions
Who can join the NCT05865327 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Rib Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05865327 currently recruiting?
Yes, NCT05865327 is actively recruiting participants. Contact the research team at ben.safa@sunnybrook.ca for enrollment information.
Where is the NCT05865327 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05865327 clinical trial?
NCT05865327 is sponsored by Sunnybrook Health Sciences Centre. The principal investigator is Ben Safa, MD at Sunnybrook Health Sciences Centre. The trial plans to enroll 24 participants.