Recruiting

Cryo Rib Fracture

Sponsor:

University of Minnesota

Code:

NCT06347874

Conditions

Rib Fractures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cryoablation

ESP Catheter

Study Details

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.

Conditions

Rib Fractures

Study ID

NCT06347874

Start date

Jan 10, 2025

Status verified date

Feb, 2026

Completion date

Mar 13, 2027

Anticipated

Primary completion date

Feb 13, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cryoablation

Participants with rib fracture randomized to Cryoablation.

active comparator: ESP catheter

Participants with rib fracture randomized to ESP Catheter.

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Candace Nelson

nelso377@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

More Information

Sponsor

University of Minnesota

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-02-17.