Cryoablation for Rib Fractures

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Loma Linda University

Must not be taking: Opioids

Disqualifiers: Spinal fracture, Cognitive impairment, others

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether percutaneous cryoablation, a technique that freezes nerves, can improve healing in people with multiple rib fractures. Cryoablation reduces pain by freezing nerves, and researchers aim to determine if it enhances pain relief, breathing, and overall quality of life compared to standard pain management. The trial includes individuals with at least two rib fractures and significant pain who struggle to breathe deeply. Participants will be divided into two groups: one receiving standard care and the other receiving cryoablation in addition to standard care. This research seeks better ways to support recovery from rib fractures. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve recovery methods for rib fractures.

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

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using chronic opioids, you may not be eligible to participate.

What prior data suggests that percutaneous cryoablation is safe for rib fractures?

Research has shown that freezing the nerves between the ribs, known as percutaneous cryoablation, is generally safe. In one study, nearly 5% of patients with broken ribs who received this treatment experienced fewer complications while in the hospital. Another series of cases found it to be a safe and effective way to manage pain in older adults with rib fractures.

Cryoablation works by temporarily stopping nerve function, which helps control pain. Studies have not reported major safety concerns, indicating it is well-tolerated. However, like any procedure, risks exist, so discussing these with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about percutaneous cryoablation for rib fractures because it offers a unique approach to pain management. Unlike standard pain treatments that often rely on medications like opioids or nerve blocks, cryoablation works by freezing the intercostal nerves, which can reduce pain by directly targeting the source. This method could potentially offer faster pain relief and reduce the need for systemic medications, minimizing side effects and the risk of addiction. Additionally, the minimally invasive nature of cryoablation means it could be an option for patients who prefer to avoid surgery or heavy medications.

What evidence suggests that percutaneous cryoablation is effective for rib fractures?

Research has shown that percutaneous cryoablation, a procedure that freezes the nerves near the ribs, can significantly reduce pain for several weeks or even months. In this trial, some participants will receive a standard multi-modal pain regimen with percutaneous cryoablation, while others will receive the standard pain regimen alone. Studies have found that cryoablation lowers pain levels in people with rib fractures, and many do not need extra pain medication afterward. Cryoablation temporarily stops the nerve signals that cause pain, aiding in long-term recovery. This method provides pain relief by temporarily altering the nerve structure. Overall, these findings suggest that percutaneous cryoablation could effectively manage pain from rib fractures. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with traumatic rib fractures. It's designed to help those experiencing chest pain, respiratory issues, or other complications from broken ribs. Participants should be able to undergo the procedure and follow-up tests.

Inclusion Criteria

I am older than 18 years.

Presence of > 2 rib fractures

Incentive Spirometry < 60% of predicted

Exclusion Criteria

I do not have bleeding disorders or shock currently.

Life Expectancy < 6 months

I have rib fractures from CPR.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Treatment

Participants undergo randomization and receive either percutaneous cryoablation or standard multimodal pain therapy

Immediate

1 visit (in-person)

Pulmonary Recovery Evaluation

Participants participate in tests at pre-determined intervals to evaluate their pulmonary recovery

Up to 1 year

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, respiratory mechanics, and quality of life

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Percutaneous Cryoablation of Intercostal Nerves

Trial Overview The study compares percutaneous cryoablation—a technique that freezes nerves—to standard pain treatments in managing rib fracture outcomes. It looks at how each method affects pain relief, breathing function, quality of life, and delirium rates over time.

How Is the Trial Designed?

Group I: Standard multi-modal pain regimen with percutaneous cryoablation Experimental Treatment 2 Interventions

Group II: Standard multi-modal pain regimen alone Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Published Research Related to This Trial

Intercostal nerve cryoablation (INCA) combined with surgical stabilization of rib fractures (SSRF) significantly reduces post-operative hospital length of stay (HLOS) and narcotic consumption, making it a beneficial addition to SSRF.

While the initial hospital charges on the day of surgery were higher for the INCA group, the overall hospital charges remained similar, and the INCA group had significantly lower charges after surgery, indicating that the benefits of INCA justify the costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical stabilization of rib fractures combined with intercostal nerve cryoablation proves to be more cost effective by reducing hospital length of stay and narcotics. Bauman, ZM., Loftus, J., Raposo-Hadley, A., et al.[2021]

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]

In a case study of 3 trauma patients with rib fractures, video-assisted thoracoscopic cryoablation of intercostal nerves effectively managed pain without causing respiratory complications like pneumonia or atelectasis post-surgery.

At one-month follow-up, all patients reported complete relief from chest pain and did not require opiate analgesics, suggesting that cryoablation can enhance respiratory function and reduce the need for ventilators in patients with unstable rib fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoablation for Chest Wall Trauma: A Brief Report. Farley, P., Buckley, CT., Mullen, PR., et al.[2022]

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]

Image-guided percutaneous intercostal nerve cryoablation, using cone-beam computed tomography and software-assisted planning, is a feasible method for treating chronic post-thoracotomy pain syndrome (PTPS).

In a case study, this technique provided approximately 8 weeks of significant pain relief for a patient suffering from intractable PTPS, suggesting it may be a valuable option for managing this challenging condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided nerve cryoablation for post-thoracotomy pain syndrome. Koethe, Y., Mannes, AJ., Wood, BJ.[2021]

Citations

1. rapm.bmj.com rapm.bmj.com/content/early/2025/11/03/rapm-2025-106973

Ultrasound-guided, percutaneous cryoneurolysis of ... Most importantly, cryoneurolysis provides weeks to months of pain relief, which better matches the prolonged recovery period associated with rib ...

2. 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 data showed that patients treated with PCNIN had significant reductions in pain scores and required no additional pain control interventions ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022480424005328

Inpatient Outcomes of Intercostal Nerve Cryoablation With ... This national analysis spanning 4 y of data found that nearly 5% of patients with rib fractures undergoing SSRF received INCA as an adjunct treatment. The (+) ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11307162/

Percutaneous Cryoneurolysis for Pain Control After Rib ... Cryoneurolysis of intercostal nerves can provide 3 to 6 months of reversible anesthesia by inducing Wallerian degeneration of the nerve axons ...

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

Early Percutaneous Cryoablation for Pain Control After Rib ... The purpose of this study is to provide long-term pain control for elderly patients with rib fractures in order to minimize their risk of complications and ...

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

Role of intercostal nerve block and cryoneurolysis in the ... Cryoneurolysis provides extended yet reversible pain control by temporarily disrupting intercostal nerve function. Comparative studies suggest ...

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

Percutaneous Cryoneurolysis for Pain Control After Rib ... This case series demonstrated that PCNIN is a safe and effective pain management modality after rib fractures in adults 65 years or older.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11344524/

Bedside percutaneous cryoneurolysis technique for ... Our study demonstrates patients with rib fractures may experience improved pain ratings and IS max values after INC.