Cryoneurolysis for Rib Fractures
(UNPIN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you have chronic pain and use more than 30mg of oral morphine equivalent per day, you may not be eligible to participate.
Is cryoneurolysis safe for treating rib fractures?
How is cryoneurolysis different from other treatments for rib fractures?
What data supports the effectiveness of the treatment Cryoneurolysis for rib fractures?
Research shows that intercostal nerve cryoablation, a form of cryoneurolysis, can reduce pain, decrease the need for opioids, and shorten hospital stays for patients with rib fractures. Additionally, ultrasound-guided cryoablation has been effective in providing pain relief for other conditions, like post-surgery pain, by targeting specific nerves without complications.12348
Who Is on the Research Team?
Ben Safa, MD
Principal Investigator
Sunnybrook Health Sciences Centre
Are You a Good Fit for This Trial?
This trial is for adults over 18 who've been admitted to the hospital within the last 48 hours with unilateral traumatic rib fractures (3 to 8 ribs). They must be candidates for a specific pain block catheter. People can't join if they have chronic pain, substance use disorders, certain medical conditions that prevent safe participation, or are unable to follow up after three months.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cryoneurolysis or sham procedure along with standard care analgesia
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term monitoring
Participants record pain medications and pain scores in a diary
What Are the Treatments Tested in This Trial?
Interventions
- Cryoneurolysis
- Sham Cryoneurolysis
Cryoneurolysis is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunnybrook Health Sciences Centre
Lead Sponsor