Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 24-012333
About this study
Traumatic rib fractures occur in approximately 10% of trauma patients. [1] These injuries are often associated with severe pain, which contributes to significant morbidities such as atelectasis and pneumonia. [2,3] The pathophysiology behind this process centers on pain, causing the impairment of adequate pulmonary function and clearance of secretions. [4] In addition, mortality rates of 29% have been reported in patients with seven or more rib fractures1. Appropriate and adequate analgesia for these injuries has been shown to decrease rates of pneumonia, ventilator days, and mortality. [4,5] However, the treatment of traumatic chest wall pain is often not a short-term endeavor. Prior studies have reported that 59% of patients continue to have persistent pain at two months after injury. [6] When followed to 6 months, 28% of isolated rib fracture patients still experienced chest wall pain. [7]
Most modern analgesia modalities have a short duration of effect (< 72 hours) and require repeated doses for effective treatment. Also, many of these modalities have contraindications for use (i.e., epidural catheters with coagulopathy or spinal fractures and NSAIDS with renal dysfunction or gastrointestinal bleeding). Historically the predominant form of analgesic therapy fell to opioid medications. However, the past decade has seen dramatic increases in opioid-related deaths from drug overdose. In 2017 alone, 47,600 deaths from drug overdoses were caused by the opioid class of medications. Of these deaths, 15,000 were directly attributable to commonly prescribed opioids such as oxycodone and morphine. [8] As a result, the United States declared a national emergency on August 10th, 2017, and emphasis had been placed on limiting the prescriptions of all opioid medication by providers. [9]
The technique of intercostal nerve cryoablation (IC) may be a useful adjunct to provide both short and long-term analgesia for traumatic rib fracture pain. IC for control of post-thoracotomy pain was first described by Nelson and colleagues in 1974 [10] In terms of efficacy for thoracotomy pain, multiple trials have shown that IC has equal or improved efficacy as compared to intermittent intravenous and oral opioids. Often the performance of IC showed significantly decreased narcotic use, improved pain control, and improved compliance with pulmonary physiotherapy as compared to controls. [11,12,13,14,15,16,17]
The current medical literature does not provide a clear consensus on the best modality for treating pain associated with rib fractures. [18 – 23] However, recent advancements like radiofrequency ablation [23] and cryoneurolysis [21] have shown promising results in managing this pain. Despite their potential, there has been no comprehensive comparison of these newer methods with traditional pain management techniques. This gap in research underscores the need for more studies to determine the most effective and safe pain management strategy for patients suffering from rib fracture-related pain. Such studies would be crucial in optimizing patient care and could potentially offer alternatives that mitigate the risks associated with opioid use and other conventional treatments.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Ability to read, comprehend, and sign informed consent form.
- Willingness to adhere to the study instructions
- Age ≥ 18 years.
- Traumatic injured patients with three or more rib fractures with significant fracture displacement, or with segmental fractures necessitating surgical stabilization.
Exclusion Criteria:
- Non-English-speaking patients.
- Patients without the mental capacity to consent. for the study either due to traumatic injury or baseline mental capacity.
- Rib fractures with only posterior fracture line - i.e., medial to the tip of the scapula with arms at side position.
- Prior thoracotomy or pulmonary resection on the side of anticipated surgery.
- Blunt Pulmonary Contusion Score (BPC) > 12
- 5. Intubation prior to study enrollment.
- Moderate or Severe TBI.
- Spinal cord injury with severity greater than ASIA E classification.
- Expected laparotomy, craniotomy/craniectomy, spine fixation, pelvic fixation.
- Pregnancy
- Incarceration
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 12/23/2024. Questions regarding updates should be directed to the study team contact.