Cryoablation for Rib Fracture Pain Control

Overseen By Alexandra Myers

Age: 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: 1

Duration: 1 month

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to control long-term pain for older adults with rib fractures. Researchers will compare a new treatment called cryoneurolysis, which uses cold to numb nerves, against the standard care usually provided after such injuries. They aim to determine if this new method can help patients recover more quickly and with fewer complications. Individuals aged 65 or older, with a rib fracture causing significant pain, and admitted to the Stanford Emergency Department after an injury, might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative pain management research.

Do I have to stop taking my current medications for the trial?

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 cryoneurolysis is safe for rib fracture pain control?

Research has shown that percutaneous cryoneurolysis, a method that freezes nerves to block pain, is quite safe. Studies have found it effective for managing pain from broken ribs, especially in older adults. This treatment successfully reduces the need for strong painkillers, aiding recovery. Reports of serious side effects are rare, making it a well-tolerated option for pain relief. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cryoablation for rib fracture pain control because it offers a novel way to manage pain. Unlike traditional options like pain medications or nerve blocks, cryoablation uses extreme cold to target and temporarily disable the nerves responsible for pain, potentially providing longer-lasting relief. This method is minimally invasive and can be precisely guided with imaging, which may reduce the risk of complications and improve recovery times. For patients 65 and older, this approach could mean better pain management with fewer side effects from medications.

What evidence suggests that cryoneurolysis could be effective for rib fracture pain control?

In this trial, participants will be randomized to receive either cryoneurolysis or standard-of-care treatment for rib fracture pain. Research has shown that cryoneurolysis is a promising method for treating pain from broken ribs. Studies have found that this approach can significantly reduce pain and lessen the need for opioid painkillers. It uses cold temperatures to temporarily block pain signals from the nerves around the ribs. This treatment has improved life after injury by providing effective pain relief. Additionally, cryoneurolysis is considered safe and effective when used alongside standard pain management for individuals with rib fractures. ^{1 2 3 6 7}

Who Is on the Research Team?

Joseph D Forrester, MD

Principal Investigator

Stanford University

Nishita Kothary, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for elderly patients over 65 with acute rib fractures who experience significant pain (score of 5 or higher) when taking deep breaths. They must be admitted to Stanford Emergency Department and have no metastasis to ribs, severe coagulation issues, very low GCS scores, or specific rib fracture locations that make them unsuitable for the treatment.

Inclusion Criteria

I am over 65 and have a recent rib fracture.

Presenting and admitted to Stanford Emergency Department

I experience significant pain when taking a deep breath.

Exclusion Criteria

Only certain ribs (1, 2, 10, 11, 12) being broken will exclude you from participating.

My rib fracture is close to my spine.

Your Glasgow Coma Scale (GCS) score is less than 13, which means you may have severe brain injury or impairment.

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 percutaneous image-guided cryoneurolysis (pICN) or standard-of-care treatment within 72 hours of presentation

1 month

Daily monitoring during hospital stay

Follow-up

Participants are monitored for pain control and functional outcomes after discharge

12 months

Regular follow-up visits and daily pain score assessments

What Are the Treatments Tested in This Trial?

Interventions

• Cryoneurolysis
• Standard of Care

Trial Overview The study is testing a procedure called cryoneurolysis against standard care in managing pain after rib fractures in elderly patients. The goal is to see if this technique can provide long-term relief and help patients return to their normal activities by minimizing complications.

How Is the Trial Designed?

Group I: Image-guided percutaneous ICN (pICN): Group A Experimental Treatment 1 Intervention

Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.

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

Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138325001810

Ultrasound-guided percutaneous cryoneurolysis of ... This study examines the analgesic effect of ultrasound-guided percutaneous cryoneurolysis of intercostal nerves in traumatic rib fractures.

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

Ultrasound-guided Percutaneous Cryoneurolysis for the ... Ultrasound-guided percutaneous cryoneurolysis involves reversibly ablating peripheral nerve(s) using exceptionally low temperature with a transdermal probe.

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

Percutaneous Cryoneurolysis for Pain Control After Rib ... This case series evaluates changes in numeric pain scores, opioid use, and other measures before, during, and 30 days after computed ...

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. facs.org facs.org/for-medical-professionals/news-publications/news-and-articles/acs-brief/august-20-2024-issue/percutaneous-cryoneurolysis-of-intercostal-nerves-is-effective-pain-control-for-rib-fracture-in-older-adults/

Percutaneous Cryoneurolysis of Intercostal Nerves Is ... The authors concluded that PCNIN was a safe and effective addition to conventional analgesic protocols for management of pain due to multiple rib fractures.

6. ajronline.org ajronline.org/doi/10.2214/AJR.17.18452

Percutaneous Image-Guided Cryoneurolysis | AJR Percutaneous image-guided cryoneurolysis is safe and effective for the management of several well-described syndromes involving neuropathic pain.

7. ccts.amegroups.org ccts.amegroups.org/article/view/104585/html

Role of intercostal nerve block and cryoneurolysis in the ... According to epidemiological studies, rib fractures are associated with mortality rates of up to 10% and complication rates of approximately 13% ...