24 Participants Needed

Cryoneurolysis for Rib Fractures

(UNPIN Trial)

BS
Overseen ByBen Safa, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Sunnybrook Health Sciences Centre
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

Cryoneurolysis, including ultrasound-guided and intercostal nerve cryoablation, has been used safely in humans for pain management in various conditions, with studies reporting no serious complications.12345

How is cryoneurolysis different from other treatments for rib fractures?

Cryoneurolysis is unique because it uses extreme cold to temporarily disable nerves, providing targeted pain relief without the need for drugs. This treatment can reduce the need for opioids and shorten hospital stays, making it a novel option for managing pain from rib fractures.12467

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?

BS

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

I am a candidate for an ESP block catheter procedure.
I have between 3 to 8 broken ribs from an injury on one side.
I was admitted to the hospital within the last 48 hours.

Exclusion Criteria

My BMI is over 45.
I do not have major injuries that would prevent me from sitting up or lying on my side.
I do not have conditions like cryoglobulinemia, cold hemoglobinuria, multiple myeloma, or cold urticaria.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cryoneurolysis or sham procedure along with standard care analgesia

Up to 7 days
Daily visits while in hospital

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
Follow-ups at 1h, 24h, 48h, 1 week, 1 month, and 3 months post block procedure

Long-term monitoring

Participants record pain medications and pain scores in a diary

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Cryoneurolysis
  • Sham Cryoneurolysis
Trial Overview The study is testing cryoneurolysis—a technique using extreme cold to freeze nerves and reduce pain—against a sham procedure in patients with broken ribs from trauma. It aims to see if this method plus standard care works better than standard care alone in managing pain over three months.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cryoneurolysis GroupExperimental Treatment1 Intervention
Group II: Standard Care GroupPlacebo Group1 Intervention

Cryoneurolysis is already approved in United States for the following indications:

🇺🇸
Approved in United States as Cryoneurolysis for:

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Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials
693
Recruited
1,569,000+

Published Research Related to This Trial

Ultrasound-guided percutaneous cryoneurolysis significantly reduced pain levels on postoperative day 2 after mastectomy, with active treatment participants reporting a median pain score of 0 compared to 3 in the sham group (P < 0.001).
The technique also led to a dramatic reduction in opioid use during the first three weeks post-surgery, with the active group using only 1.5 mg of oxycodone compared to 72 mg in the sham group, and resulted in lower rates of chronic pain after one year (3% in active vs 17% in sham, P < 0.001).
Preoperative Ultrasound-guided Percutaneous Cryoneurolysis for the Treatment of Pain after Mastectomy: A Randomized, Participant- and Observer-masked, Sham-controlled Study.Ilfeld, BM., Finneran, JJ., Swisher, MW., et al.[2023]
Intercostal nerve cryoablation (IC) during surgical stabilization of rib fractures (SSRF) was found to be safe and feasible, with no significant immediate or long-term complications reported among the 20 patients who underwent the procedure.
While the study did not show a significant reduction in pain scores or opioid use for the SSRF-IC group compared to the SSRF group, further research is needed to fully evaluate the analgesic efficacy of IC for rib fractures.
Intercostal nerve cryoablation during surgical stabilization of rib fractures.Choi, J., Min, JG., Jopling, JK., et al.[2023]
Ultrasound-guided cryoablation of intercostal nerves has been successfully performed in four patients with postthoracotomy pain syndrome, providing pain relief for at least one month without any complications.
The use of ultrasound enhances the safety of the procedure by allowing visualization of the pleura, which is particularly beneficial in thin patients, potentially reducing the risk of pneumothorax and improving the success rate of cryoablation.
Ultrasound-guided intercostal nerve cryoablation.Byas-Smith, MG., Gulati, A.[2016]

Citations

Preoperative Ultrasound-guided Percutaneous Cryoneurolysis for the Treatment of Pain after Mastectomy: A Randomized, Participant- and Observer-masked, Sham-controlled Study. [2023]
Intercostal nerve cryoablation during surgical stabilization of rib fractures. [2023]
Ultrasound-guided intercostal nerve cryoablation. [2016]
Short communication: ultrasound-guided percutaneous cryoanalgesia of intercostal nerves for uniportal video-assisted thoracic surgery. [2022]
Intercostal nerve cryoablation during surgical stabilization of rib fractures decreases post-operative opioid use, ventilation days, and intensive care days. [2023]
Ultrasound-Guided Cryoanalgesia of Peripheral Nerve Lesions. [2017]
Intercostal Cryoneurolysis. [2023]
Ultrasound-Guided Percutaneous Cryoneurolysis for Post-Thoracotomy Pain Syndrome: A Case Report. [2023]
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