Cryoablation for Rib Fractures

Overseen By Candace Nelson

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Minnesota

Disqualifiers: Pregnancy, Cold urticaria, Intubation, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 7 days

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if cryoablation can better control pain from broken ribs compared to an ESP catheter. Cryoablation freezes the nerves to block pain signals, while the ESP catheter delivers pain medication directly to the area. Individuals with multiple broken ribs and no other major exclusionary issues may qualify. The trial compares the effectiveness of each method for pain relief one week after the procedure. As a Phase 4 trial, this research explores how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for these treatments?

Research has shown that cryoablation, a method using extreme cold to numb nerves, is generally safe for treating broken ribs. One study examined 135 cryoablation treatments in 20 patients and found it both safe and practical. Another study found that patients undergoing cryoablation during rib fracture surgery experienced fewer complications in the hospital.

Cryoablation also appears to alleviate pain, reducing the need for narcotics, which can aid recovery. Overall, studies suggest that cryoablation is a safe and effective method for managing pain from broken ribs. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Cryoablation is unique because it uses extreme cold to target and numb the nerves around rib fractures, potentially offering pain relief without the need for opioids or invasive surgery. Unlike standard care options like pain medication or nerve blocks, cryoablation can provide longer-lasting relief by directly disrupting nerve signals. Researchers are excited about this approach because it could reduce recovery times and minimize the side effects associated with traditional pain management techniques.

What evidence suggests that this trial's treatments could be effective for rib fractures?

This trial will compare cryoablation with the ESP catheter for managing pain in patients with rib fractures. Studies have shown that cryoablation, which freezes nerves to reduce pain, effectively manages pain in patients with broken ribs. Specifically, patients who underwent cryoablation reported significantly lower pain levels, with relief lasting at least 30 days after the procedure. Another study found that this method can reduce the need for strong painkillers, known as narcotics. Additionally, cryoablation is considered safe and practical, with fewer complications when used during surgeries to stabilize ribs. Overall, evidence suggests that cryoablation offers promising pain relief for patients with rib fractures. ^{1 2 4 5 6}

Who Is on the Research Team?

Neil Hanson

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults over the age of 18 who have suffered from multiple rib fractures. It's not specified who can't join, but typically those with conditions that might interfere with the treatment or skew results would be excluded.

Inclusion Criteria

I am over 18 and have multiple broken ribs.

Exclusion Criteria

Patients who are pregnant via self-report or positive pregnancy test

Non-English speakers

Patients with cold urticaria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cryoablation of the intercostal nerves or receive an ESP catheter for rib fracture pain management

7 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores and opioid use

30 days

Multiple assessments (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Cryoablation
• ESP Catheter

Trial Overview The study is testing whether cryoablation (freezing) of nerves between ribs offers better pain control after 7 days compared to using an ESP (Erector Spinae Plane) catheter, which delivers local anesthesia near the spine.

How Is the Trial Designed?

Group I: Cryoablation Experimental Treatment 1 Intervention

Participants with rib fracture randomized to Cryoablation.

Group II: ESP catheter Active Control 1 Intervention

Participants with rib fracture randomized to ESP Catheter.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

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 study involving 101 elderly patients with rib fractures, those treated with coolant spray experienced significantly greater pain relief compared to those receiving a placebo, particularly within the first 60 minutes after application.

The results suggest that coolant spray therapy is an effective analgesic option for managing pain in geriatric patients with rib fractures, supporting its use as part of a multimodal pain management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of coolant spray on rib fracture pain of geriatric blunt thoracic trauma patients: a randomized controlled trial. Akbaş, İ., Dogruyol, S., Kocak, AO., et al.[2023]

A patient with painful sclerotic metastases in the thoracic and sacral spine experienced successful pain relief through image-guided percutaneous cryoablation, demonstrating the efficacy of this treatment for managing tumor-related pain.

The use of insulation techniques and thermosensors during the cryoablation procedure highlights advancements in safety and precision, potentially improving outcomes for patients with similar conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sclerotic vertebral metastases: pain palliation using percutaneous image-guided cryoablation. de Freitas, RM., de Menezes, MR., Cerri, GG., et al.[2014]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34446656/

Intercostal nerve cryoablation during surgical stabilization ... This pilot study performing 135 intercostal nerve cryoablations on 20 patients suggests that IC is safe and feasible for patients undergoing SSRF.

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

Inpatient Outcomes of Intercostal Nerve Cryoablation With ... Nearly 5% of SSRF patients received INCA. While overall LOS was similar, the (+)INCA cohort had decreased ICU LOS and in-hospital complications.

3. tsaco.bmj.com tsaco.bmj.com/content/9/1/e001521

Bedside percutaneous cryoneurolysis technique for ... This technique aims to provide non-opioid, long-term pain relief in patients with rib fractures who are not surgical candidates.

4. 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.

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

Percutaneous Cryoneurolysis for Pain Control After Rib ... Patients had significantly decreased pain scores after the procedure, and the analgesic effect persisted as expected at 30-day follow-up, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11750013/

Rib fracture management: A review of surgical stabilization ... Intercostal nerve cryoablation is safe and effective pain reducing adjunct to SSRF. ... Outcome after surgical stabilization of rib fractures versus nonoperative ...