Freezing Nerves to Relieve Pain from Rib Fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the feasibility of using cryoneurolysis, a technique that freezes intercostal nerves to alleviate pain from traumatic rib fractures. Participants with unilateral rib fractures will be randomly assigned to receive either cryoneurolysis or a sham procedure within 48 hours of hospital admission. The study aims to assess pain levels and medication usage over a three-month period following the intervention. If successful, this pilot study will pave the way for a larger trial to compare the effectiveness of cryoneurolysis combined with standard pain management techniques against standard techniques alone.

Why it matters

Who can join: the full rules

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

Where it's running

• Sunnybrook Health Sciences Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Ben Safa, MD — Sunnybrook Health Sciences Centre
• Study coordinator: Ben Safa, MD
• Email: ben.safa@sunnybrook.ca
• Phone: 416-480-4864

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.