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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this double blinded randomized control trial is to learn if percutaneous cryoablation of traumatic rib fractures improves outcomes. The main questions it aims to answer are: Does percutaneous cryoablation improve short and long term pain scores? Does percutaneous cryoablation improve short and long term respiratory mechanics? Does percutaneous cryoablation improve long term quality of life? Does percutaneous cryoablation decrease delirium? Researchers will compare cryoablation to standard multimodal pain therapy to see if this impacts respiratory recovery. Participants will undergo randomization, percutaneous cryoablative procedure, and participate in tests at pre-determined intervals to evaluate their pulmonary recovery.

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 data supports the effectiveness of the treatment Percutaneous Cryoablation of Intercostal Nerves for rib fractures?

Research shows that cryoablation of intercostal nerves can help control pain, reduce the need for opioid painkillers, and shorten hospital stays for patients with rib fractures. It has also been effective in improving respiratory status and reducing ventilator dependency in patients with chest trauma. ^{1 2 3 4 5}

Is cryoablation for rib fractures safe?

Research suggests that cryoablation of intercostal nerves for rib fractures is generally safe, with studies reporting no immediate or long-term complications and no post-operative respiratory issues like pneumonia. It has been used successfully in patients to manage pain without significant side effects. ^{1 2 3 4 5}

How is the treatment Percutaneous Cryoablation of Intercostal Nerves unique for rib fractures?

Percutaneous Cryoablation of Intercostal Nerves is unique because it provides targeted and long-lasting pain relief by freezing the nerves around the ribs, which can reduce the need for opioid painkillers and help patients recover faster without the complications associated with other treatments like surgery. ^{1 2 3 5 6}

Eligibility Criteria

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

Life Expectancy < 6 months

I have extensive air pockets under my skin.

I do not have bleeding disorders or shock currently.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 (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]

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]

References

1. 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]

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

Cryoablation for Chest Wall Trauma: A Brief Report. [2022]

4. Netherlands 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. [2021]

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

Image-guided nerve cryoablation for post-thoracotomy pain syndrome. [2021]

6. Turkey pubmed.ncbi.nlm.nih.gov

CT-guided cryoablation for post-thoracotomy pain syndrome: a retrospective analysis. [2020]