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NCT Number: NCT06347874

Cryo Rib Fracture Study

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.

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Key information

Conditions

Rib Fractures Fractures, Bone Thoracic Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location status: Recruiting

Location contact

Allicia Bulleri

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cryoablation

Drug

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

ESP Catheter

Drug

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 outcomes

  1. Maximum pain score on POD (Post Operative Day) 7

    Time frame: 7 days post procedure

    Maximum pain score on POD (Post Operative Day) 7

  2. Opioid Use

    Time frame: 30 days post procedure

    Opioid Use measured in MMEs

  3. Functional Pain Scores

    Time frame: 30 days post procedure

    Functional Pain Scores on POD 0,1,2,3,4,5,6,7,and 30

  4. Number of Patients using opioids at POD 30

    Time frame: 30 days post procedure

    , Number of Patients using opioids at POD 30

  5. Length of hospital stay

    Time frame: 30 days post procedure

    Length of hospital stay measured in days:hours:minutes

  6. Number of patients returned home by POD 30

    Time frame: 30 days post procedure

    Number of patients returned home by POD 30

  7. time to first ambulation

    Time frame: 30 days post procedure

    time to first ambulation measured in days:hours:minutes

  8. number of patients admitted to ICU

    Time frame: 30 days post procedure

    number of patients admitted to ICU

  9. number of patients that required mechanical ventilation

    Time frame: 30 days post procedure

    number of patients that required mechanical ventilation

  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Candace Nelson

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 4, 2024
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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