UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture

NCT05865327 | Recruiting

• 1 other identifier: 5715
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Traumatic rib fractures (i.e., broken ribs caused by a physical injury) are common and very painful. They also often lead to serious complications, more time spent in hospital, and can even lead to death. Even after rib fractures have healed, they can lead to long-term pain and a lower quality of life. A technology called cryoneurolysis, which acts to freeze nerves causing pain using a small tool which can turn very cold, is a promising new way to manage rib fracture pain. This study is a test with a small number of people to see if it is feasible to use this technology for patients with rib fractures. If this is successful, we will recruit more people for a larger study to see if cryoneurolysis, along with standard pain control techniques, is better at stopping pain, compared to just the normal techniques alone. Participants in our study will be asked to rate their pain, and record pain medications that they take for 3 months after their pain procedure.

Conditions

Rib Fractures; Rib Fracture Multiple; Rib; Fracture, With Flail Chest; Pain; Pain, Acute; Pain, Chronic; Trauma; Trauma Injury

Keywords

Cryoneurolysis; Rib Fracture Pain; Intercostal Nerve Block

Outcome Measures

Primary Outcomes (4)

• Number of participants randomized over an 8 month period

  Goal of 3 participants per month for 8 months

  Entire pilot study (approximately 8 months)

• Number of participants able to adhere to the protocol

  Goal of \> 90%

  Entire pilot study (approximately 8 months + 3 month follow-up)

• Number of participants able to adhere to the follow-up

  Goal of \> 90%

  3 month follow-up

• Rate of Adverse events

  Ensure no adverse events (short or long term) associated with CN

  3 month follow-up

Secondary Outcomes (16)

• Pain Severity during deep inspiration 24 hours post ESP catheter placement

  24 hours post placement of ESP catheter

• Time to discontinuation of ESP catheter

  Until ESP catheter removal (usually < 7 days)

• ESP catheter use

  Until ESP catheter removal (usually < 7 days)

• Opioid consumption in hospital and after discharge

  Daily for 90 days after block placement

• Pain Intensity at 1 and 3 months

  1 and 3 month follow-ups

Other Outcomes (1)

• Pain Intensity

  1h and 48h, post block placement, daily in hospital, weekly post discharge and at 1 week follow-up

Study Arms (2)

Cryoneurolysis Group

EXPERIMENTAL

In addition to all standard of care analgesia treatments, CN will be performed on the ICN of each broken rib using the Iovera CN device and Generation 2 Iovera tip under ultrasound guidance.

Procedure: Cryoneurolysis

Standard Care Group

SHAM COMPARATOR

Participants in the control group will receive all standard of care analgesia treatments as well as sham CN (i.e., application of device without skin puncture or activation of unit) to maintain participant blinding.

Procedure: Sham Cryoneurolysis

Interventions

Cryoneurolysis PROCEDURE

Cryoneurolysis will be performed on the intercostal nerve associated with each fractured rib using a handheld cryoneurolysis machine (Iovera). Cryoneurolysis will consist of two 103 second cycles (includes cooling, ice ball formation and warming time) per rib fracture level. Ultrasound guidance will be used to identify appropriate rib fracture levels and to target the device tip in real time. All participants will also receive standard multimodal analgesia and ESP catheter infusion.

Cryoneurolysis Group

Sham Cryoneurolysis PROCEDURE

Participants in the control group will receive sham CN (i.e., application of device without skin puncture or activation of unit) to maintain participant blinding. All participants will also receive standard multimodal analgesia and ESP catheter infusion.

Standard Care Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18
• Unilateral traumatic rib fractures (3 to 8)
• Candidate for ESP block catheter
• Within 48hrs of admission to hospital

You may not qualify if:

• Lack of patient consent; unlikely to comply with follow up
• Unable to use Patient Controlled Regional Analgesia (Ventilated/sedated patients or Moderate to severe traumatic brain injury)
• Chronic pain (opioid use \> 30mg oral morphine equivalent per day)
• Substance use disorder
• CrCl \< 50
• BMI \> 45
• Significant distracting injuries (unreduced long bone fractures, unstable pelvic or spine fractures and patients requiring trauma laparotomy- also preclude positioning for block placement (lateral decubitus or sitting up))
• Contraindications for ESP catheter placement (pre-existing medical/neurological/hematologic diseases, localized infection/trauma at site of intervention, allergy to amide local anesthetics)
• Contraindications to CN (cryoglobulinemia, paroxysmal cold hemoglobinuria, multiple myeloma and cold urticarial).
• Unable to return to Trauma Recovery Clinic (in-person or virtual) at 3 months

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

RECRUITING

MeSH Terms

Conditions

Rib Fractures; Fractures, Bone; Pain; Acute Pain; Chronic Pain; Wounds and Injuries; Accidental Injuries

Condition Hierarchy (Ancestors)

Thoracic Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ben Safa, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ben Safa, MD

CONTACT

416-480-4864; ben.safa@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the anesthesiologist responsible for performing cryoneurolysis will be aware of group allocation. All others, including participants, other clinical team, data collectors and analysts will be blinded. Participants in the control group will receive sham cryoneurolysis to maintain blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-centre, prospective, parallel, randomized, blinded (participant, data collectors/analysts) pilot feasibility trial

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 18, 2023
• Study Start: October 23, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: This is a pilot trial and full inferential analysis will not be conducted until completion of the full trial. As such, data will be available following publication of the primary results of the subsequent full trial.
• Access Criteria: Data and supporting information will be made available following reasonable request directly to study PI.

Locations

CA (1)