Cryo Rib Fracture Study

April 2, 2024 updated by: University of Minnesota

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryoablation
Participants with rib fracture randomized to Cryoablation.
Drug: Cryoablation
an injection of 1ml of 1% lidocaine per rib and ultrasound guided cryoablation of the intercostal nerves
Active Comparator: ESP catheter
Participants with rib fracture randomized to ESP Catheter.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum pain score on POD (Post Operative Day) 7
Time Frame: 7 days post procedure
Maximum pain score on POD (Post Operative Day) 7
7 days post procedure
Opioid Use
Time Frame: 30 days post procedure
Opioid Use measured in MMEs
30 days post procedure
Functional Pain Scores
Time Frame: 30 days post procedure
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
Time Frame: 30 days post procedure
, Number of Patients using opioids at POD 30
30 days post procedure
Length of hospital stay
Time Frame: 30 days post procedure
Length of hospital stay measured in days:hours:minutes
30 days post procedure
Number of patients returned home by POD 30
Time Frame: 30 days post procedure
Number of patients returned home by POD 30
30 days post procedure
time to first ambulation
Time Frame: 30 days post procedure
time to first ambulation measured in days:hours:minutes
30 days post procedure
number of patients admitted to ICU
Time Frame: 30 days post procedure
number of patients admitted to ICU
30 days post procedure
number of patients that required mechanical ventilation
Time Frame: 30 days post procedure
number of patients that required mechanical ventilation
30 days post procedure
Pulmonary Function Testing.
Time Frame: 30 days post procedure
Pulmonary Function Tests include spirometry. For patients with pulmonary function testing, the test results between the two groups.
30 days post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Neil Hanson, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANES-2024-32820

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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