Cryo Rib Fracture Study

Phase 4

Recruiting

• Conditions: Rib Fractures
• Interventions: Drug: ESP Catheter; Drug: Cryoablation

• Registration Number: NCT06347874
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-04-02
• Study First Posted: 2024-04-04
• Study Start: 2025-01-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2027-01-20
• Study Completion: 2027-07-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESP catheter	ESP Catheter	Participants with rib fracture randomized to ESP Catheter.
Cryoablation	Cryoablation	Participants with rib fracture randomized to Cryoablation.

Primary Outcome Measures

Name	Time	Method
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 returned home by POD 30	30 days post procedure	Number of patients returned home by POD 30
number of patients admitted to ICU	30 days post procedure	number of patients admitted to ICU
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.
Opioid Use	30 days post procedure	Opioid Use measured in MMEs
Maximum pain score on POD (Post Operative Day) 7	7 days post procedure	Maximum pain score on POD (Post Operative Day) 7
Length of hospital stay	30 days post procedure	Length of hospital stay measured in days:hours:minutes
Number of Patients using opioids at POD 30	30 days post procedure	, Number of Patients using opioids at POD 30
time to first ambulation	30 days post procedure	time to first ambulation measured in days:hours:minutes
number of patients that required mechanical ventilation	30 days post procedure	number of patients that required mechanical ventilation

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States