Cryoneurolysis for Rib Fracture Pain

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen by Brian Ilfeld, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, San Diego

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

Thoracic trauma frequently involve rib fractures which can be very painful for 2-3 months. Unfortunately, pain is not simply a "symptom" of the injuries, but a significant cause of additional medical problems: pain causes people to breath and cough less deeply/often which increases the risk of collapsing little parts of the lung. These collapsed areas often lead to complications which can increase the risk of death. In addition, the higher the amount of pain in the weeks following the fracture, the higher the risk of developing persistent, chronic pain that can last indefinitely. So, providing excellent pain control is very important for a variety of reasons. Various nerve blocks can greatly decrease pain, but even the longest acting are measured in hours or days, and not the weeks and months for which rib fracture pain can last. Therefore, opioids-"narcotics"-are the most common pain control method provided to patients; but they frequently do not provide enough pain control, have undesirable side effects like nausea and vomiting, and are sometimes misused which can lead to addiction or overdose. A prolonged nerve block lasting multiple months from a single treatment may be provided by freezing the nerve using a process called "cryoneurolysis". With cryoneurolysis and ultrasound machines, a very small "probe" may be placed through anesthetized skin and guided to the target nerve to allow freezing. The procedure takes about 5 minutes for each nerve, involves little discomfort, has no side effects, and cannot be misused or addictive. After 2-3 months, the nerve returns to normal functioning. The investigators have completed a small study suggesting that a single cryoneurolysis treatment provides potent short- and long-term pain relief following thoracic trauma with rib fractures. The ultimate objective of the proposed research is to determine if percutaneous cryoneurolysis is an effective non-opioid, single-application treatment for pain following traumatic rib fracture. The current project is a pragmatic, multicenter, randomized, triple-masked (investigators, participants, statisticians), sham/placebo-controlled, parallel-arm, human-subjects, post-market clinical trial to determine if cryoneurolysis is an effective non-opioid treatment for pain following traumatic rib fractures.

Research Team

Brian Ilfeld, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

Adults over 18 with moderate pain from 1-6 recent rib fractures, who are getting a single-injection nerve block. Excluded if on blood thinners, have infections at the probe site, need oxygen for lung issues, have certain cold-related diseases or diabetes, use opioids regularly, can't use an incentive spirometer, have other painful injuries needing opioids, or require continuous nerve blocks.

Inclusion Criteria

I am receiving a nerve block injection for my rib fracture pain.

I have 1-6 rib fractures from an injury within the last 60 hours, confirmed by imaging.

I experience moderate to severe pain (at least a 5 out of 10) in my fractured rib area even when resting.

Exclusion Criteria

Chest tube

Inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access)

Pregnancy

Treatment Details

Interventions

• Cryoneurolysis (Procedure)
• Local anesthetic peripheral nerve block (Procedure)
• Sham Cryoneurolysis (Procedure)
• Sham peripheral nerve block (Procedure)

Trial Overview The trial is testing cryoneurolysis—a way to relieve pain by freezing nerves—against sham treatments in patients with traumatic rib fractures. It's a multicenter study where participants and researchers don't know who gets real treatment versus placebo to see if it effectively manages pain without opioids.

Participant Groups

Group I: Cryoneurolysis Active Control 2 Interventions

Active cryoneurolysis of the intercostal nerve of each fractured rib along with one cephalad and one caudad will be targeted: for each nerve the cryoneurolysis device will be triggered using 3 cycles of 2-minute nitrous oxide activation separated by 1-minute defrost periods (Epimed) or for the Varian: 5.5-minute \[all but 5 participants\] or 3-minute \[5th - 12th participants; changes based on new laboratory and subsequently clinical data\] argon activation (2000 psi starting at 100% power but decreased to keep return gas flow temperature warmer than -100C) followed by a 30-second helium defrost. For the active comparator, the gas will be deployed to the tip where a drop in temperature will result in cryoneurolysis.

Group II: Sham Procedure Placebo Group 2 Interventions

Sham cryoneurolysis of the intercostal nerve of each fractured rib along with one cephalad and one caudad will be targeted: for each nerve the cryoneurolysis device will be triggered using 3 cycles of 2-minute nitrous oxide activation separated by 1-minute defrost periods (Epimed) or for the Varian: 1 cycle of 5.5 minutes \[all but 5 participants\] or 3 minutes \[5th - 12th participants; changes based on new laboratory and subsequently clinical data\] of argon and 30 seconds of helium. However, for the sham comparator, the gas will NOT be deployed to the tip, there there will NOT be a drop in temperature, and NO cryoneurolysis will occur.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Dr. Christopher Longhurst

University of California, San Diego

Chief Medical Officer since 2021

MD and MS in Medical Informatics from UC Davis

Patty Maysent

University of California, San Diego

Chief Executive Officer since 2016

MBA from Stanford University

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Colonel Mark G. Hartell

Congressionally Directed Medical Research Programs

Director, Congressionally Directed Medical Research Programs since 2022

PhD in Analytical Chemistry from Auburn University, MS in Biophysical Chemistry from Ohio State University, BS in Chemistry from State University of New York at Oswego

Dr. Sarah Goldman

Congressionally Directed Medical Research Programs

Chief Medical Officer since 2023

MD