Cryoneurolysis for Rib Fractures

(UNPIN Trial)

Overseen By Ben Safa, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Opioids

Disqualifiers: Chronic pain, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Up to 7 days

24 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

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. ^{1 2 3 4 8}

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

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.

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?

Group I: Cryoneurolysis Group Experimental Treatment 1 Intervention

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.

Group II: Standard Care Group Placebo Group 1 Intervention

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.

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

Approved in United States as Cryoneurolysis for:

• Pain management for traumatic rib fractures
• Postoperative pain relief

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).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided intercostal nerve cryoablation. Byas-Smith, MG., Gulati, A.[2016]

Ultrasound-guided percutaneous cryoanalgesia effectively targets intercostal nerves to provide postoperative pain relief after thoracic surgery, which is crucial for improving lung function and reducing complications.

Using a high-frequency ultrasound probe allows for precise placement of the cryoprobe near the intercostal nerve, confirmed by specific ultrasound signs, enhancing the efficacy of the cryoanalgesia technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short communication: ultrasound-guided percutaneous cryoanalgesia of intercostal nerves for uniportal video-assisted thoracic surgery. Nicolás, M., Acosta, CM., Martinez Ferro, M., et al.[2022]

In a study of 241 patients undergoing surgical stabilization of rib fractures, those who received intercostal nerve cryoablation used significantly fewer opioids post-operatively and had shorter stays in the intensive care unit compared to those who did not receive cryoablation.

Cryoablation did not increase the time spent in surgery or the risk of pulmonary complications, making it a safe adjunctive treatment that enhances pain management without additional risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intercostal nerve cryoablation during surgical stabilization of rib fractures decreases post-operative opioid use, ventilation days, and intensive care days. Marturano, MN., Thakkar, V., Wang, H., et al.[2023]

Ultrasound guidance during cryoneurolysis allows for real-time monitoring of needle placement, leading to more accurate targeting of peripheral nerves and improved outcomes in pain relief.

Patients have reported varying degrees of long-term pain relief and functional improvement from cryoneurolysis, with no serious complications noted, suggesting it is a safe alternative to other pain management techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Cryoanalgesia of Peripheral Nerve Lesions. Djebbar, S., Rossi, IM., Adler, RS.[2017]

Intercostal cryoneurolysis is a promising treatment for managing chest wall pain that is difficult to control with standard medications, particularly after chest surgery or injuries.

This technique uses extreme cold to damage the targeted intercostal nerve, leading to pain relief through a process called Wallerian degeneration, although careful patient selection and awareness of potential complications are essential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intercostal Cryoneurolysis. Huang, J., Delijani, K., El Khudari, H., et al.[2023]

Ultrasound-guided percutaneous cryoneurolysis of the intercostal nerves was successfully used to treat a 40-year-old male with severe post-thoracotomy pain syndrome (PTPS) that had persisted for two years.

The treatment resulted in a 75% reduction in pain immediately after the procedure, with sustained 50% pain relief for eight weeks, suggesting that this method is a safe and effective option for managing chronic PTPS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Percutaneous Cryoneurolysis for Post-Thoracotomy Pain Syndrome: A Case Report. Perese, J., Oswald, J., Gabriel, RA.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Preoperative Ultrasound-guided Percutaneous Cryoneurolysis for the Treatment of Pain after Mastectomy: A Randomized, Participant- and Observer-masked, Sham-controlled Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Intercostal nerve cryoablation during surgical stabilization of rib fractures. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided intercostal nerve cryoablation. [2016]

4. Italy pubmed.ncbi.nlm.nih.gov

Short communication: ultrasound-guided percutaneous cryoanalgesia of intercostal nerves for uniportal video-assisted thoracic surgery. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Intercostal nerve cryoablation during surgical stabilization of rib fractures decreases post-operative opioid use, ventilation days, and intensive care days. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Cryoanalgesia of Peripheral Nerve Lesions. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Intercostal Cryoneurolysis. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Percutaneous Cryoneurolysis for Post-Thoracotomy Pain Syndrome: A Case Report. [2023]