Ultrasound-Guided Percutaneous Cryoneurolysis to Treat Pain Following Thoracic Trauma

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Oct 1, 2023

Keywords

ClinConnect Summary

The investigators propose a pragmatic, multicenter, randomized, triple-masked (investigators, participants, statisticians), sham/placebo-controlled, parallel-arm, human-subjects clinical trial to determine if cryoneurolysis is an effective non-opioid treatment for pain following traumatic rib fractures. Participants will be recruited at 6 enrolling centers:

* Brigham and Women's Hospital, Boston, Massachusetts
* University of Texas, Houston, Houston, Texas
* Massachusetts General Hospital, Boston, Massachusetts
* University of California, San Diego, San Diego, California
* Walter Reed Nati...

Gender

ALL

Eligibility criteria

• 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