Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoablation | Experimental | Participants with rib fracture randomized to Cryoablation. |
|
| ESP catheter | Active Comparator | Participants with rib fracture randomized to ESP Catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoablation | Drug | an injection of 1ml of 1% lidocaine per rib and ultrasound guided cryoablation of the intercostal nerves |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum pain score on POD (Post Operative Day) 7 | Maximum pain score on POD (Post Operative Day) 7 | 7 days post procedure |
| Opioid Use | Opioid Use measured in MMEs | 30 days post procedure |
| Functional Pain Scores | Functional Pain Scores on POD 0,1,2,3,4,5,6,7,and 30 | 30 days post procedure |
| Number of Patients using opioids at POD 30 | , Number of Patients using opioids at POD 30 | 30 days post procedure |
| Length of hospital stay | Length of hospital stay measured in days:hours:minutes | 30 days post procedure |
| Number of patients returned home by POD 30 | Number of patients returned home by POD 30 | 30 days post procedure |
| time to first ambulation | time to first ambulation measured in days:hours:minutes | 30 days post procedure |
| number of patients admitted to ICU | number of patients admitted to ICU | 30 days post procedure |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Candace Nelson | Contact | nelso377@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Neil Hanson | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55414 | United States |
Not provided
| ID | Term |
|---|---|
| D012253 | Rib Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D013898 | Thoracic Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
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.
Not provided
Not provided
The individual doing the outcome assessments will be blinded.
| ESP Catheter | Drug | 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. |
|
| number of patients that required mechanical ventilation | number of patients that required mechanical ventilation | 30 days post procedure |
| Pulmonary Function Testing. | Pulmonary Function Tests include spirometry. For patients with pulmonary function testing, the test results between the two groups. | 30 days post procedure |