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UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture, a Pilot Randomized Control Trial (UNPIN Trial)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Aged ≥18

• Unilateral traumatic rib fractures (3 to 8)

• Candidate for ESP block catheter

• Within 48hrs of admission to hospital

Locations
Other Locations
Canada
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Contact Information
Primary
Ben Safa, MD
ben.safa@sunnybrook.ca
416-480-4864
Time Frame
Start Date: 2023-10-23
Estimated Completion Date: 2025-12
Participants
Target number of participants: 24
Treatments
Experimental: Cryoneurolysis Group
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.
Sham_comparator: Standard Care Group
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.
Related Therapeutic Areas
Sponsors
Leads: Sunnybrook Health Sciences Centre

This content was sourced from clinicaltrials.gov