Cryo Rib Fracture Study

NCT06347874 | Recruiting Phase 4 FDA Drug

• 1 other identifier: ANES-2024-32820
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (10)

• Maximum pain score on POD (Post Operative Day) 7

  Maximum pain score on POD (Post Operative Day) 7

  7 days post procedure

• Opioid Use

  Opioid Use measured in MMEs

  30 days post procedure

• Functional Pain Scores

  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

  , Number of Patients using opioids at POD 30

  30 days post procedure

• Length of hospital stay

  Length of hospital stay measured in days:hours:minutes

  30 days post procedure

• Number of patients returned home by POD 30

  Number of patients returned home by POD 30

  30 days post procedure

• time to first ambulation

  time to first ambulation measured in days:hours:minutes

  30 days post procedure

• number of patients admitted to ICU

  number of patients admitted to ICU

  30 days post procedure

• number of patients that required mechanical ventilation

  number of patients that required mechanical ventilation

  30 days post procedure

• 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

Study Arms (2)

Cryoablation

EXPERIMENTAL

Participants with rib fracture randomized to Cryoablation.

Drug: Cryoablation

ESP catheter

ACTIVE COMPARATOR

Participants with rib fracture randomized to ESP Catheter.

Drug: ESP Catheter

Interventions

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.

ESP catheter

Cryoablation DRUG

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

Cryoablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are over 18 who have more than one ribs fractured.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Conditions

Rib Fractures

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Neil Hanson

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Candace Nelson

CONTACT

nelso377@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The individual doing the outcome assessments will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized prospective controlled trial. This will be single blinded trial. The individual doing the outcome assessments will be blinded. Randomization will be 1:1.

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 4, 2024
• Study Start: January 10, 2025
• Primary Completion (Estimated): February 13, 2027
• Study Completion (Estimated): March 13, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)