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Single Nerve-Freezing treatment could replace opioids for broken ribs

NCT ID NCT06069154

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

bone fracture Rib Fractures

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.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • University of California, San Diego

    La Jolla, California, 92037, United States

  • University of Texas, Houston

    Houston, Texas, 77054, United States

  • 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.