Single Nerve-Freezing treatment could replace opioids for broken ribs
NCT ID NCT06069154
First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times
Summary
This study tests a one-time nerve-freezing procedure called cryoneurolysis to treat pain from broken ribs. The treatment uses a small probe to freeze the nerves around the fractured ribs, providing pain relief for up to 2-3 months without the side effects or addiction risk of opioids. The trial involves 120 adults with rib fractures and compares the freezing procedure to a sham treatment to see if it reduces pain and opioid use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cryoneurolysis (nerve freezing using a device)
- What this could lead to
- If it works, this could provide months of pain relief from a single treatment, reducing the need for opioids and their side effects.
- What could go wrong
- This is an early-stage trial with only 120 participants, so results may not apply to everyone. The procedure may not work as well as hoped, and nerve freezing carries a small risk of temporary numbness or weakness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult patients of at least 18 years of age 2. A total of 1-6 traumatic rib fractures confirmed by imaging at least 3 cm distal to the costotransverse joint sustained within the previous 60 h (bilateral fractures are acceptable, but the total of the two sides combined must not exceed 6 fractures) 3. Pain in the fractured rib(s) region rated at least moderate (5 on the 0-10 Numeric Rating Scale) at rest 4. Undergoing a single-injection peripheral nerve block to treat the pain of the rib fracture(s) Exclusion Criteria: 1. Anticoagulation or bleeding disorder: introduction of the percutaneous cryoneurolysis probe has a risk of hemorrhage similar to the percutaneous insertion of a similar gauge needle; but an anticoagulated state will increase the risk of hemorrhage (aspirin in doses for cardiothoracic/stroke prophylaxis \[≤ 325 mg\] are acceptable). 2. Infection at the site of probe introduction: percutaneous insertion of the probe through a cutaneous infection would bring an unacceptable risk of introducing the infection to deeper tissues. 3. Pulmonary disease or injury requiring supplemental oxygen: one theoretical risk of cryoneurolysis is a unilateral pneumothorax (not reported) which could result in a compromised pulmonary state for patients who require supplemental oxygen at baseline. 4. Neurologic deficit of the intercostal nerves of the fractured ribs: cryoneurolysis is theoretically a potent analgesic, but it does not "heal" injured nerves. Therefore, nerve deficits-either pre-existing or due to the trauma-will confound the analgesia-related results. 5. Possessing any contraindication to decreased temperature such as cryoglobulinemia, cryofibrinogenemia, cold urticaria paroxysmal cold hemoglobinuria, or Raynaud's disease: the decreased temperature accompanying cryoneurolysis could result in local tissue/vascular compromise for patients with any of these cold-triggered syndromes/diseases. 6. Insulin-dependent diabetes: laboratory studies have demonstrated impaired nerve regeneration in diabetic animals, and diabetes in patients can lead to impaired regeneration of axons and recovery following investigational nerve injury as well as focal neuropathies such as ulnar neuropathy and carpal tunnel syndrome. Whether these findings are applicable to cryoneurolysis in patients with diabetes remains unknown, but we prefer to error on the side of caution for study participants. 7. Chronic opioid use (daily use within the 2 weeks prior to the fracture and duration of use \> 4 weeks): individuals using opioids on a chronic basis will continue their baseline opioid requirements following the traumatic event. This will confound the analgesic results of the study. 8. Inability to use an incentive spirometer: One of the Specific Aims involves improving functioning by decreasing pain using cryoneurolysis, and this will be evaluated using an incentive spirometer. For this reason, patients who are intubated or for whom there is anticipation of intubation will be excluded. 9. Any injury outside of the fractured rib(s) which results in moderate pain (NRS \> 3) and/or anticipated to require opioid analgesics: such injuries would confound the results for the intervention under investigation. 10. An existing or planned continuous neuraxial or peripheral nerve block. 11. Fracture of the 1st rib on either side 12. Flail chest (3 or more adjacent ribs, each fractured in more than one location to create a free-floating segment) 13. Chest tube 14. Any degree of decreased mental capacity as determined by the surgical service or investigators. 15. Inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access). 16. Pregnancy 17. Incarceration 18. Number and location of fractures would require more than 10 intercostal nerves to be treated with cryoneurolysis
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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University of California, San Diego
La Jolla, California, 92037, United States
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University of Texas, Houston
Houston, Texas, 77054, United States
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Walter Reed National Military Medical Center
Bethesda, Maryland, 20814, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could a simple nerve block cut pneumonia risk after rib fractures?
- Topical gel could ease rib fracture pain in the ER
- Pain relief showdown for broken ribs: IV lidocaine vs nerve block
- Rib fracture surgery: does age matter more than injury severity?
- New study aims to find best painkiller for broken ribs after surgery
- New device aims to improve rib fracture repair