Recruiting

Cryoneurolysis

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05865327

Conditions

Rib Fractures

Rib Fracture Multiple

Rib; Fracture, With Flail Chest

Pain

Pain, Acute

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cryoneurolysis

Sham Cryoneurolysis

Study Details

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

Study ID

NCT05865327

Start date

Oct 23, 2023

Status verified date

Sep, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cryoneurolysis Group

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.

sham comparator: Standard Care Group

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.

Interventions

Cryoneurolysis

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.

Sham Cryoneurolysis

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.

Primary outcome measure

  • Number of participants randomized over an 8 month period [ Time Frame: Entire pilot study (approximately 8 months) ]
  • Number of participants able to adhere to the protocol [ Time Frame: Entire pilot study (approximately 8 months + 3 month follow-up) ]
  • Number of participants able to adhere to the follow-up [ Time Frame: 3 month follow-up ]
  • Rate of Adverse events [ Time Frame: 3 month follow-up ]

Central Contacts and Locations

Central contacts

Ben Safa, MD

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

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N3M5

Contacts

Ben Safa

416 480 4864ben.safa@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Sep 12, 2025

Last verified

Sep, 2025

Keywords

  • Cryoneurolysis
  • Rib Fracture Pain
  • Intercostal Nerve Block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2025-09-12.