Cryoneurolysis for Rib Fractures

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for managing pain in individuals with rib fractures using a technique called cryoneurolysis. The treatment employs the Iovera Smart Tip 190 device, which numbs the nerves around the fractured ribs with cold, potentially providing long-lasting pain relief. Participants will receive either the cryoneurolysis treatment or standard pain management care. Suitable candidates for this trial include those with rib fractures between ribs 3 and 9, experiencing significant pain when breathing deeply, and admitted to the emergency department for a traumatic injury. As an unphased trial, this study offers patients the chance to explore innovative pain management options that could significantly enhance their quality of life.

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.

What prior data suggests that the Iovera Smart Tip 190 is safe for cryoneurolysis in rib fracture patients?

Research has shown that the FDA has approved the Iovera Smart Tip 190 device for cryoneurolysis, a treatment that freezes nerves to reduce pain. This approval indicates the treatment is generally safe. The device creates a precise ice ball that targets nerves, relieving pain without harming nearby tissues.

In past studies, patients using this device experienced significant pain relief, with few reports of side effects, which were usually minor. This suggests the treatment is safe and effective for managing pain from rib fractures. However, as with any medical treatment, results can vary, so discussing concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ultrasound-guided cryoneurolysis for rib fractures because it offers a new way to manage pain. Unlike standard treatments that rely on multi-modal pain therapy, cryoneurolysis directly targets intercostal nerves using the Iovera Smart Tip 190 device. This technique potentially provides long-lasting pain relief by freezing these nerves, which could reduce the need for ongoing medication and improve patient comfort soon after an injury. This innovative approach stands out as it provides targeted relief with potentially fewer side effects compared to traditional pain management methods.

What evidence suggests that the Iovera Smart Time 190 is effective for rib fracture pain relief?

This trial will compare two treatment approaches for rib fractures. One group of participants will receive standard-of-care treatment, typically involving multi-modal pain therapy and pulmonary toilet. Another group will undergo ultrasound-guided cryoneurolysis using the Iovera Smart Tip 190. Research has shown that the Iovera Smart Tip 190 effectively reduces pain from rib fractures. In other studies, patients experienced significant pain relief after this treatment. This method works by freezing the nerves around the ribs, stopping pain signals. The FDA has approved the Iovera device for this use, ensuring its safety. Initial findings suggest this method provides both short-term and long-term pain relief while the ribs heal. ^{1 2 3 6 7}

Who Is on the Research Team?

Ara Ko, MD

Principal Investigator

Stanford University

Joseph D Forrester, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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 have a recent fracture in one of my middle ribs.

I experience significant pain when taking a deep breath.

Presenting and admitted to Stanford Emergency Department

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05330611

Treatment of Adult Traumatic Rib Fractures With ... The purpose of this research study is to examine the effectiveness of using the Iovera Smart Time 190, for minimally invasive ultrasound-guided cryoneurolysis, ...

2. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/t/NCT05330611.html

Treatment of Adult Traumatic Rib Fractures With Percutaneous ... 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 ...

3. clinicaltrial.be clinicaltrial.be/en/details/17533?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Treatment of Adult Traumatic Rib Fractures With Percutane... The purpose of this research study is to examine the effectiveness of using the Iovera Smart Time 190, for minimally invasive ...

4. med.stanford.edu med.stanford.edu/gensurg/research/activeclinicaltrials?ctid=NCT05330611&conditionId=&serviceLineId=&condition=&alpha=t

Active Clinical Trials | Division of General Surgery 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 ...

5. ioverapro.com ioverapro.com/iovera_Intercostal_Case_Report.pdf

Administration Case Report With iovera° Patient was given a single-shot ESP block to anesthetize the intercostal nerves to prevent any pain associated with the iovera° procedure on those nerves.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11801435/

Ultrasound-guided Percutaneous Cryoneurolysis for the ... Traumatic rib fractures are associated with pain lasting weeks to months and a decreased ability to inspire deeply or cough to clear secretions.

7. ioverapro.com ioverapro.com/administrative-case-reports

Administrative Case Reports This case report represents the individual experience of Dr Pieter Vreede and is intended to demonstrate his methodology for using iovera° to treat rib fracture ...