Cryoneurolysis for Rib Fracture Pain

Enrolling by invitation at 6 trial locations

Overseen By Brian Ilfeld, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Anticoagulants, Chronic opioids

Disqualifiers: Pulmonary disease, Neurologic deficit, Insulin-dependent diabetes, 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: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing pain from broken ribs using cryoneurolysis, a technique that freezes nerves to provide long-lasting relief without opioids. The researchers aim to determine if this treatment can reduce pain and prevent complications such as lung issues and chronic pain. Participants will receive either the actual cryoneurolysis treatment or a placebo, which mimics the procedure but is not real. Individuals who have recently broken 1-6 ribs and are experiencing moderate pain may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative pain management research that could lead to new treatment options.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes those with chronic opioid use and certain conditions like anticoagulation or insulin-dependent diabetes. It's best to discuss your specific medications with the trial team.

What prior data suggests that cryoneurolysis is safe for treating rib fracture pain?

Research has shown that cryoneurolysis is generally safe for treating pain from broken ribs. One study found this treatment to be a safe and effective addition to regular pain management for individuals with multiple broken ribs. Participants in that study experienced significant pain relief without serious side effects. Another report described a small group of patients who also achieved successful pain relief with cryoneurolysis, again without notable adverse events.

In these studies, cryoneurolysis involved using a small tool to freeze the nerve and block pain. Patients tolerated this method well, experiencing minimal discomfort during the procedure. Importantly, there were no reports of addiction or misuse, which can be a concern with other pain treatments like opioids. Overall, the evidence suggests that cryoneurolysis is a safe option for managing pain from broken ribs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Cryoneurolysis is unique because it targets rib fracture pain directly by freezing the intercostal nerves, which are responsible for transmitting pain signals. Unlike standard treatments like oral pain medications or nerve blocks, which can have systemic effects or require repeated dosing, cryoneurolysis offers a localized and potentially longer-lasting solution. Researchers are excited about this technique because it could provide significant pain relief without the side effects associated with systemic medications, and it has the potential to improve recovery times by allowing patients to breathe and move more comfortably.

What evidence suggests that cryoneurolysis could be an effective treatment for rib fracture pain?

Research has shown that cryoneurolysis, a treatment under study in this trial, can significantly relieve pain for people with rib fractures. This procedure freezes the nerves, providing pain relief that lasts as long as the pain from the fractures. Patients reported less pain and reduced opioid use in the weeks following treatment. Another study found that it improved quality of life by reducing the need for narcotics, which often carry side effects and addiction risks. Early findings also suggest that cryoneurolysis might help prevent long-term chronic pain after rib fractures. ^{1 4 6 7 8}

Who Is on the Research Team?

Brian Ilfeld, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

Adults over 18 with moderate pain from 1-6 recent rib fractures, who are getting a single-injection nerve block. Excluded if on blood thinners, have infections at the probe site, need oxygen for lung issues, have certain cold-related diseases or diabetes, use opioids regularly, can't use an incentive spirometer, have other painful injuries needing opioids, or require continuous nerve blocks.

Inclusion Criteria

I am receiving a nerve block injection for my rib fracture pain.

I have 1-6 rib fractures from an injury within the last 60 hours, confirmed by imaging.

I experience moderate to severe pain (at least a 5 out of 10) in my fractured rib area even when resting.

Exclusion Criteria

Chest tube

Inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access)

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cryoneurolysis or sham procedure for pain management following thoracic trauma

1 day

1 visit (in-person)

Post-treatment Monitoring

Participants are monitored for opioid consumption and pain levels over the first 2 months

8 weeks

Regular follow-ups (in-person and virtual)

Follow-up

Participants are monitored for long-term outcomes including chronic pain and pulmonary complications

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Cryoneurolysis
• Local anesthetic peripheral nerve block
• Sham Cryoneurolysis
• Sham peripheral nerve block

Trial Overview The trial is testing cryoneurolysis—a way to relieve pain by freezing nerves—against sham treatments in patients with traumatic rib fractures. It's a multicenter study where participants and researchers don't know who gets real treatment versus placebo to see if it effectively manages pain without opioids.

How Is the Trial Designed?

Group I: Cryoneurolysis Active Control 2 Interventions

Active cryoneurolysis of the intercostal nerve of each fractured rib along with one cephalad and one caudad will be targeted: for each nerve the cryoneurolysis device will be triggered using 3 cycles of 2-minute nitrous oxide activation separated by 1-minute defrost periods (Epimed) or for the Varian: 5.5-minute \[all but 5 participants\] or 3-minute \[5th - 12th participants; changes based on new laboratory and subsequently clinical data\] argon activation (2000 psi starting at 100% power but decreased to keep return gas flow temperature warmer than -100C) followed by a 30-second helium defrost. For the active comparator, the gas will be deployed to the tip where a drop in temperature will result in cryoneurolysis.

Group II: Sham Procedure Placebo Group 2 Interventions

Sham cryoneurolysis of the intercostal nerve of each fractured rib along with one cephalad and one caudad will be targeted: for each nerve the cryoneurolysis device will be triggered using 3 cycles of 2-minute nitrous oxide activation separated by 1-minute defrost periods (Epimed) or for the Varian: 1 cycle of 5.5 minutes \[all but 5 participants\] or 3 minutes \[5th - 12th participants; changes based on new laboratory and subsequently clinical data\] of argon and 30 seconds of helium. However, for the sham comparator, the gas will NOT be deployed to the tip, there there will NOT be a drop in temperature, and NO cryoneurolysis will occur.

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?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11801435/

Ultrasound-guided Percutaneous Cryoneurolysis for the ... Ultrasound-guided percutaneous cryoneurolysis involves reversibly ablating peripheral nerve(s) using exceptionally low temperature with a transdermal probe.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138325001810

Ultrasound-guided percutaneous cryoneurolysis of ... This study examines the analgesic effect of ultrasound-guided percutaneous cryoneurolysis of intercostal nerves in traumatic rib fractures.

3. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2821962

Percutaneous Cryoneurolysis for Pain Control After Rib ... This case series evaluates changes in numeric pain scores, opioid use, and other measures before, during, and 30 days after computed ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7533180/

Ultrasound-guided percutaneous intercostal nerve ... Ultrasound-guided percutaneous cryoneurolysis is a modality that has the potential to provide analgesia matching the duration of pain following rib fractures.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04482582

Early Percutaneous Cryoablation for Pain Control After Rib ... The application of cryoneurolysis will help reduce the amount of narcotics the patient would need, and potentially lead to a better post-injury quality of life.

6. facs.org facs.org/for-medical-professionals/news-publications/news-and-articles/acs-brief/august-20-2024-issue/percutaneous-cryoneurolysis-of-intercostal-nerves-is-effective-pain-control-for-rib-fracture-in-older-adults/

Percutaneous Cryoneurolysis of Intercostal Nerves Is ... The authors concluded that PCNIN was a safe and effective addition to conventional analgesic protocols for management of pain due to multiple rib fractures.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31684715/

Ultrasound-guided percutaneous intercostal nerve ... Case: This case series describes five patients with rib fractures whose pain was successfully treated with cryoneurolysis. Conclusions: Ultrasound-guided ...

8. ccts.amegroups.org ccts.amegroups.org/article/view/104585/html

Role of intercostal nerve block and cryoneurolysis in the ... According to epidemiological studies, rib fractures are associated with mortality rates of up to 10% and complication rates of approximately 13% ...