Rib Fractures
Conditions
Brief summary
The purpose of this study is to determine if patients with rib fractures who undergo cryoablation of the intercostal nerves have improved pain control 7 days from procedure when compared to those who have a ESP catheter.
Interventions
DRUGCryoablation
an injection of 1ml of 1% lidocaine per rib and ultrasound guided cryoablation of the intercostal nerves
DRUGESP Catheter
an ultrasound guided erector spinae plane catheter with initial bolus of 30 mL of 0.25% bupivacaine followed by infusion of 0.2% ropivacaine at 10 mL per hour via programmed intermittent bolus.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The individual doing the outcome assessments will be blinded.
Intervention model description
This is a randomized prospective controlled trial. This will be single blinded trial. The individual doing the outcome assessments will be blinded. Randomization will be 1:1.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are over 18 who have more than one ribs fractured.
Exclusion criteria
* Patients who have an exclusion to regional anesthesia. * Patients who are pregnant via self-report or pregnancy test if they take one. * Non-English speakers * Patients who have cold urticaria * Patients with bilateral fractures * Patients currently intubated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum pain score on POD (Post Operative Day) 7 | 7 days post procedure | Maximum pain score on POD (Post Operative Day) 7 |
| Opioid Use | 30 days post procedure | Opioid Use measured in MMEs |
| Functional Pain Scores | 30 days post procedure | Functional Pain Scores on POD 0,1,2,3,4,5,6,7,and 30 |
| Number of Patients using opioids at POD 30 | 30 days post procedure | , Number of Patients using opioids at POD 30 |
| Length of hospital stay | 30 days post procedure | Length of hospital stay measured in days:hours:minutes |
| Number of patients returned home by POD 30 | 30 days post procedure | Number of patients returned home by POD 30 |
| time to first ambulation | 30 days post procedure | time to first ambulation measured in days:hours:minutes |
| number of patients admitted to ICU | 30 days post procedure | number of patients admitted to ICU |
| number of patients that required mechanical ventilation | 30 days post procedure | number of patients that required mechanical ventilation |
| Pulmonary Function Testing. | 30 days post procedure | Pulmonary Function Tests include spirometry. For patients with pulmonary function testing, the test results between the two groups. |
Countries
United States
Contacts
CONTACTCandace Nelson
PRINCIPAL_INVESTIGATORNeil Hanson
University of Minnesota
Outcome results
None listed