Cryoneurolysis for Rib Fracture Pain
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.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it excludes those with chronic opioid use and certain conditions like anticoagulation or insulin-dependent diabetes. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment Cryoneurolysis for rib fracture pain?
Research shows that intercostal nerve cryoablation, a form of cryoneurolysis, can help control pain, reduce the need for opioids, and shorten hospital stays for patients with rib fractures. Additionally, ultrasound-guided cryoanalgesia has been effective in providing pain relief after thoracic surgeries.12345
Is cryoneurolysis safe for treating rib fracture pain?
Cryoneurolysis, used for rib fracture pain and other conditions, has been shown to be safe in studies, with no immediate or long-term complications reported. It is a technique that uses very low temperatures to target nerves and has been performed successfully without complications in various cases.12356
How is the treatment Cryoneurolysis for rib fracture pain different from other treatments?
Cryoneurolysis is unique because it uses extremely low temperatures to temporarily block pain signals by targeting specific nerves, offering pain relief without the need for radiation or high doses of pain medication. This method can reduce the need for opioids and shorten hospital stays, making it a novel option for managing rib fracture pain.12346
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo cryoneurolysis or sham procedure for pain management following thoracic trauma
Post-treatment Monitoring
Participants are monitored for opioid consumption and pain levels over the first 2 months
Follow-up
Participants are monitored for long-term outcomes including chronic pain and pulmonary complications
Treatment Details
Interventions
- Cryoneurolysis
- Local anesthetic peripheral nerve block
- Sham Cryoneurolysis
- Sham peripheral nerve block
Cryoneurolysis is already approved in United States for the following indications:
- Pain management for traumatic rib fractures
- Postoperative pain relief
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
Congressionally Directed Medical Research Programs
Collaborator