Cryoneurolysis for Pain After Rib Fractures
This study is looking at new ways to treat pain from broken ribs. When you break ribs, it can hurt a lot for months and make it hard to breathe deeply, which can lead to other health problems. This study is testing if a procedure called cryoneurolysis, which uses cold to block nerve signals, can help reduce pain and the need for opioid medications. They are comparing cryoneurolysis to standard pain blocks (like paravertebral or erector spinae plane blocks) and also to 'sham' (inactive) versions of these treatments. The goal is to see if cryoneurolysis can offer better pain control for people aged 18 and older who have 1 to 6 rib fractures.
- Study design
- This is a randomized, triple-blinded study with 120 participants, meaning neither you, your doctors, nor the statisticians will know which treatment you receive. It compares cryoneurolysis to standard nerve blocks and sham procedures.
- What's involved
- You would receive either cryoneurolysis or a nerve block procedure. Your opioid use and pain levels will be recorded daily for the first 30 days, then every 15 days for the next month.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your opioid consumption and average pain levels will be tracked for two months after the intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Ultrasound-Guided Percutaneous Cryoneurolysis to Treat Pain Following Thoracic Trauma
At a glance
Conditions
Where it's being run
5 sites across 4 statesStudy leadership
- Brian Ilfeld, MD, MS · PRINCIPAL_INVESTIGATOR · University of California, San Diego
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Opioid consumption during first 2 post-intervention monthsPost-intervention months 1 and 2, collected on days 1, 2, 3, 7, 14, 21, 30, 45 and 60; at each collection time point, opioid use for the previous 24 hours will be recorded
Cumulative opioid dose measured in oral oxycodone equivalents following intervention for 9 specific 24-hour time points over the first 2 months following surgery. With 9 time points (post-intervention days 1, 2, 3, 7, 14, 21, 30, 45 and 60), this will encompass 216 hours in total of the first 2 post-intervention months. In order to claim that percutaneous cryoneurolysis is superior to usual and customary analgesia, at least one of Outcomes 1 and 2 must be superior while the other at least noninferior.
- Average pain during first 2 post-intervention monthsPost-intervention months 1 and 2, collected on days 1, 2, 3, 7, 14, 21, 30, 45 and 60; at each collection time point, the "average" pain score for the previous 24 hours will be recorded
The area under the curve for the "average" daily pain scores over the first 2 post-intervention months. At 9 specific time points the "average" pain score following the intervention will be measured using the numeric rating scale. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10= worst imaginable pain. In order to claim that percutaneous cryoneurolysis is superior to usual and customary analgesia, at least one of Outcomes 1 and 2 must be superior while the other at least noninferior.