Cryo Rib Fracture Study
ConditionRib Fractures
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who are over 18 who have more than one ribs fractured.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cryoablation
Drugan injection of 1ml of 1% lidocaine per rib and ultrasound guided cryoablation of the intercostal nerves
ESP Catheter
Drugan 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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: CryoablationExperimental treatment 1 intervention
Group B: ESP catheterActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Maximum pain score on POD (Post Operative Day) 7
Maximum pain score on POD (Post Operative Day) 7
Time frame
7 days post procedure2
Opioid Use
Opioid Use measured in MMEs
Time frame
30 days post procedure3
Functional Pain Scores
Functional Pain Scores on POD 0,1,2,3,4,5,6,7,and 30
Time frame
30 days post procedure4
Number of Patients using opioids at POD 30
, Number of Patients using opioids at POD 30
Time frame
30 days post procedureSponsors and contacts
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Source ClinicalTrials.gov