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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if patients with rib fractures who undergo cryoablation of the intercostal nerves have improved pain control 7 days from procedure when compared to those who have a ESP catheter.

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 data supports the effectiveness of the treatment Cryoablation for Rib Fractures?

Research shows that cryoablation, when used for rib fractures, can effectively control pain, reduce the need for opioid painkillers, and shorten hospital stays. Patients who received cryoablation reported no chest pain and were not using opiate analgesics at one-month follow-up, indicating its potential to improve recovery and respiratory status. ^{1 2 3 4 5}

How is cryoablation different from other treatments for rib fractures?

Cryoablation is unique because it involves freezing the intercostal nerves to provide targeted pain relief, which can reduce the need for opioid painkillers and shorten hospital stays. Unlike traditional pain management methods, it offers a more durable solution without the complications associated with rib fixation surgery. ^{1 2 4 5 6}

Research Team

Neil Hanson

Principal Investigator

University of Minnesota

Eligibility Criteria

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

I cannot have regional anesthesia due to a specific reason.

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

Non-English speakers

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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

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

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

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

3. Brazil pubmed.ncbi.nlm.nih.gov

Effect of coolant spray on rib fracture pain of geriatric blunt thoracic trauma patients: a randomized controlled trial. [2023]

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. 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

Sclerotic vertebral metastases: pain palliation using percutaneous image-guided cryoablation. [2014]