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Recruiting NCT06347874

Cryo Rib Fracture Study

Phase IV Interventional Rib Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cryoablation, ESP Catheter.
Who it may be relevant to
Registry conditions: Rib Fractures. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Maximum pain score on POD (Post Operative Day) 7 [Time frame: 7 days post procedure]
  • Opioid Use [Time frame: 30 days post procedure]
  • Functional Pain Scores [Time frame: 30 days post procedure]
  • Number of Patients using opioids at POD 30 [Time frame: 30 days post procedure]
  • Length of hospital stay [Time frame: 30 days post procedure]
  • Number of patients returned home by POD 30 [Time frame: 30 days post procedure]
  • time to first ambulation [Time frame: 30 days post procedure]
  • number of patients admitted to ICU [Time frame: 30 days post procedure]
  • number of patients that required mechanical ventilation [Time frame: 30 days post procedure]
  • Pulmonary Function Testing. [Time frame: 30 days post procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT06347874 · ANES-2024-32820

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗