Cryo Rib Fracture Study

Rib Fractures Clinical Trial

Official title:

Comparison of Cryoablation of Intercostal Nerves to Erector Spinae Plane Catheters in Patients With Rib Fractures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06347874
• Other study ID #: ANES-2024-32820
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 1, 2024
• Est. completion date: January 30, 2027

Study information

• Verified date: May 2024
• Source: University of Minnesota
• Contact: Candace Nelson
• Email: nelso377[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: January 30, 2027
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fractures

Intervention

Drug:
• Cryoablation
an injection of 1ml of 1% lidocaine per rib and ultrasound guided cryoablation of the intercostal nerves
• ESP 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum pain score on POD (Post Operative Day) 7	Maximum pain score on POD (Post Operative Day) 7	7 days post procedure
Primary	Opioid Use	Opioid Use measured in MMEs	30 days post procedure
Primary	Functional Pain Scores	Functional Pain Scores on POD 0,1,2,3,4,5,6,7,and 30	30 days post procedure
Primary	Number of Patients using opioids at POD 30	, Number of Patients using opioids at POD 30	30 days post procedure
Primary	Length of hospital stay	Length of hospital stay measured in days:hours:minutes	30 days post procedure
Primary	Number of patients returned home by POD 30	Number of patients returned home by POD 30	30 days post procedure
Primary	time to first ambulation	time to first ambulation measured in days:hours:minutes	30 days post procedure
Primary	number of patients admitted to ICU	number of patients admitted to ICU	30 days post procedure
Primary	number of patients that required mechanical ventilation	number of patients that required mechanical ventilation	30 days post procedure
Primary	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