Ultrasound-Guided Percutaneous Cryoneurolysis to Treat Pain Following Thoracic Trauma

Recruitment & Eligibility

Status: Enrolling by invitation

Sex: All

Target Recruitment: Not specified

Inclusion 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

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Opioid consumption during first 2 post-intervention months;Average pain during first 2 post-intervention months

Secondary Outcome Measures

Name	Time	Method
Post-Traumatic Stress Disorder checklist (PCL-5);Opioid consumption;Average pain;Worst/maximum pain;Least/lowest/minimal pain;Current pain;Brief Pain Inventory, short form (interference subscale);First 2 months area under the curve of the Brief Pain Inventory, short form (interference subscale);Pain during spirometry;Maximum voluntary inspiratory volume individual time points;First 2 months area under the curve of the maximum voluntary inspiratory volume;Awakenings due to pain;Masking assessment;Depression screening with the Patient Health Questionnaire (PHQ-2);Nociceptive vs neuropathic pain estimation;Days hospitalized;Number of participants with pulmonary complications