UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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

Primary outcome measure(s)

• Number of participants randomized over an 8 month period — Entire pilot study (approximately 8 months)
  Goal of 3 participants per month for 8 months
• Number of participants able to adhere to the protocol — Entire pilot study (approximately 8 months + 3 month follow-up)
  Goal of \> 90%
• Number of participants able to adhere to the follow-up — 3 month follow-up
  Goal of \> 90%
• Rate of Adverse events — 3 month follow-up
  Ensure no adverse events (short or long term) associated with CN

Trial sites (1)

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