Phase 4
Completed N=20
Rib Fracture Analgesia Using Cryoanalgesia
Traumatic Rib Fracture(s)
Source: ClinicalTrials.gov NCT04198662 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Maximum Inspired Volume — 2250; 1300 mL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Rib fractures are one of the most common injuries in trauma patients. These fractures are associated with significant pain as well as decreased ability to inspire deeply or cough to clear secretions, which together lead to pulmonary complications and a high degree of morbidity and mortality. Peripheral nerve blocks as well as epidural blocks have been used with success to improve pain control in rib fracture patients and have been associated with decreased pulmonary complications and improved outcomes. However, a single-injection nerve block lasts less than 24 hours; and, even a continuous nerve block is generally limited to 3-4 days. The pain from rib fractures usually persists for multiple weeks or months. In contrast to local anesthetic-induced nerve blocks, a prolonged block lasting a few weeks/months may be provided by freezing the nerve using a process called "cryoneurolysis". The goal of this multicenter, randomized, double-masked, sham-controlled, parallel-arm study is to evaluate the potential of cryoanalgesia to decrease pain and improve pulmonary mechanics in patients with rib fractures.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Inspired Volume |
1000; 1000; 2000; 1750; 2250; 1300 | — |
| SECONDARY Maximum Inspired Volume |
1000; 1000; 2000; 1750; 2250; 1300 | — |
| SECONDARY Spirometry Pain |
10; 10; 3; 5; 2; 8 | — |
| SECONDARY Brief Pain Inventory (Pain Scale) |
7; 28; 7; 21; 6; 26 | — |
| SECONDARY Brief Pain Inventory (Interference Scale) |
0; 30; 0; 24; 0; 1 | — |
| SECONDARY Sleep Disturbances Due to Pain |
0; 2; 0; 3; 0; 4 | — |
| SECONDARY Oral Opioid Consumption |
0; 35; 0; 18; 0; 15 | — |
| SECONDARY Intravenous Opioid Consumption |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Day of Discharge |
0.7; 1.4 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients of at least 18 years of age
- having a total of 1-6 rib fractures at least 3 cm distal to the costo-transverse joint sustained within the previous 3 days (bilateral fractures are acceptable, but the total of the two sides combined must not exceed 6 fractures)
- regional anesthetic requested by the admitting service
- accepting of a cryoneurolysis procedure
Exclusion Criteria
- chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks
- pregnancy
- incarceration
- inability to communicate with the investigators
- morbid obesity (body mass index > 40 kg/m2)
- possessing any contraindication specific to cryoneurolysis such as a localized infection at the treatment site, cryoglobulinemia, cold urticaria and Reynaud's Syndrome
- any patient unable to correctly perform incentive spirometry as this is the primary outcome measure
- any patient with any degree of decreased mental capacity as determined by the surgical service
- any reason an investigator believes study participation would not be in the best interest of the potential subject
- flail chest
- chest tube
- fracture of the 1st rib on either side
- any moderate or severe pain (NRS>3) unrelated to the rib fracture(s), as best determined by the patient and investigator
Data sourced from ClinicalTrials.gov (NCT04198662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.