Cryoneurolysis for Rib Fractures

Recruiting at 1 trial location

Overseen By Anisha Abreo, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Metastasis, GCS <13, Coagulopathy, 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: 31

Duration: Up to 1 month

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to examine the effectiveness of using the Iovera Smart Time 190, for ultrasound-guided cryoneurolysis, in trauma patients 18-64 years old with rib fractures that are not candidates for surgical stabilization. This will offer patients the benefits of cryoneurolysis of the intercostal nerves, thereby providing short and long term pain control while their ribs heal. The Iovera Smart Tip 190 is FDA approved for cryoneurolysis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is cryoneurolysis safe for treating rib fractures?

Cryoneurolysis, used for pain control in rib fractures, has been studied and found to be generally safe, with no immediate or long-term complications reported in the studies. Patients experienced reduced pain and lower use of narcotics, with no significant adverse events. ^{1 2 3 4 5}

How is the treatment Iovera Smart Time 190 different from other treatments for rib fractures?

Iovera Smart Time 190 uses cryoneurolysis, a technique that freezes nerves to block pain signals, providing targeted and long-lasting pain relief for rib fractures without the need for narcotics. This approach is unique because it can be performed using a hand-held device, making it suitable for managing both acute and chronic pain associated with rib fractures. ^{1 2 5 6 7}

Research Team

Ara Ko, MD

Principal Investigator

Stanford University

Joseph D Forrester, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults aged 18-64 who have arrived at Stanford Emergency Department with acute rib fractures and are experiencing significant pain (pain score ≥5) during deep breaths. It's specifically for those with fractures between ribs 3 to 9, not undergoing surgical stabilization, without metastasis to the ribs, no severe coagulopathy or low consciousness level.

Inclusion Criteria

I am between 18 and 64 years old and have a recent rib fracture.

I have a recent fracture in one of my middle ribs.

I experience significant pain when taking a deep breath.

Exclusion Criteria

Radiographic evidence of metastasis to ribs

Glasgow Coma Scale (GCS) score <13

My broken ribs are either the 1st, 2nd, 10th, 11th, or 12th.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive either ultrasound-guided cryoneurolysis or standard of care for pain management

Up to 1 month

Multiple visits (in-person) during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores and functional outcomes

12 months

Follow-up visits at 30 days, 90 days, and 365 days

Long-term Monitoring

Participants' pain levels and functional outcomes are assessed over a year

12 months

Treatment Details

Interventions

• Iovera Smart Time 190

Trial Overview The study tests the effectiveness of a device called Iovera Smart Tip 190 for cryoneurolysis on intercostal nerves in trauma patients with rib fractures. This non-surgical treatment aims to control pain while the ribs heal. Participants will receive this intervention alongside standard care.

Participant Groups

Group I: Ultrasound-guided Cryoneurolysis: Group A Experimental Treatment 1 Intervention

Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to the ultrasound-guided cryoneurolysis group within 72 hours of admission to the ED. Intervention is ultrasound-guided cryoneurolysis of intercostal nerves creating lost lasting pain relief. Device used for cryoneurolysis is Iovera Smart tip 190

Group II: Standard-of-Care : Group B Active Control 1 Intervention

Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to Standard of Care which typically includes multi-modal pain therapy and pulmonary toilet.

Iovera Smart Time 190 is already approved in United States for the following indications:

Approved in United States as Iovera Smart Tip 190 for:

• Pain related to rib fracture
• Osteoarthritis knee pain
• Pain related to mastectomy
• Pain in the hip, shoulder, foot and ankle, spine

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

In a study of 112 patients undergoing surgical stabilization of rib fractures (SSRF), those who received the intrathoracic technique required significantly less opioid medication (21.25 MME) compared to those who had the extrathoracic technique (46.20 MME) at 7-day follow-up, indicating better pain control.

The study suggests that the intrathoracic SSRF technique may be more effective for managing postoperative pain, supporting its use over the extrathoracic approach in similar surgical cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrathoracic plates versus extrathoracic plates: a comparison of postoperative pain in surgical stabilization of rib fracture technique. Tichenor, M., Reparaz, LB., Watson, C., 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 study of 26 patients undergoing surgical stabilization of rib fractures, the use of intercostal cryonerve block (CryoNB) significantly reduced opioid consumption by 25% and decreased pain scores by 22% compared to those receiving a ropivacaine elastomeric infusion pump (EIP).

Patients receiving CryoNB also had a shorter postoperative hospital stay (4 days vs. 6 days) without any increase in complications or hospital costs, suggesting that CryoNB may be a beneficial adjunct for pain management in these trauma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intercostal cryonerve block versus elastomeric infusion pump for postoperative analgesia following surgical stabilization of traumatic rib fractures. O'Connor, LA., Houseman, B., Cook, T., et al.[2023]

In a study of 20 patients undergoing robotic-assisted thoracoscopic lobectomies, those who received cryoneurolysis had significantly lower opioid consumption both during hospitalization (88.13 vs 26.92 morphine equivalents) and after discharge (118.5 vs 34.5 morphine equivalents) compared to those who did not receive the treatment.

Cryoneurolysis also allowed 70% of patients in the treatment group to recover without opioids after surgery, compared to only 20% in the control group, suggesting it is a safe and effective adjunct for reducing opioid use in post-operative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of cryoneurolysis analgesia in robotic-assisted thoracoscopic surgery (CARTS): a pilot study. Tung, J., Patel, R., Rajwani, T., et al.[2022]

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]

Cryoneurolysis, a technique using cold to numb nerves, was successfully used for the first time to manage acute pain from sternal and rib fractures in a polytrauma patient, providing significant pain relief for several weeks.

This method is portable, minimally invasive, and low risk, potentially reducing the need for opioids, shortening hospital stays, and enhancing mobility for patients with similar injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided percutaneous cryoneurolysis for management of acute sternal fracture pain. Kwater, AP., Sen, S., de Haan, JB., et al.[2023]

Intercostal cryoneurolysis has been evaluated in 23 studies involving 570 patients and shows promise as a non-narcotic adjunct for managing chest wall pain, particularly after trauma, with evidence suggesting reduced inpatient narcotic use and potentially shorter hospital stays.

The procedure is associated with a low risk of complications and does not significantly increase operative time, making it a favorable option for patients who do not respond to conventional pain management methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of intercostal cryoneurolysis as an analgesic adjunct for chest wall pain after surgery or trauma: systematic review. Cha, PI., Min, JG., Patil, A., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Intrathoracic plates versus extrathoracic plates: a comparison of postoperative pain in surgical stabilization of rib fracture technique. [2023]

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

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

3. Netherlands pubmed.ncbi.nlm.nih.gov

Intercostal cryonerve block versus elastomeric infusion pump for postoperative analgesia following surgical stabilization of traumatic rib fractures. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of cryoneurolysis analgesia in robotic-assisted thoracoscopic surgery (CARTS): a pilot study. [2022]

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

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

6. Netherlands pubmed.ncbi.nlm.nih.gov

Ultrasound-guided percutaneous cryoneurolysis for management of acute sternal fracture pain. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy of intercostal cryoneurolysis as an analgesic adjunct for chest wall pain after surgery or trauma: systematic review. [2022]