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: Unknown

110 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to provide long-term pain control for elderly patients with rib fractures in order to minimize their risk of complications and return them to baseline functional capacity

Research Team

Joseph D Forrester, MD

Principal Investigator

Stanford University

Nishita Kothary, MD

Principal Investigator

Stanford University

Eligibility Criteria

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.

Treatment Details

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.

Participant Groups

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+