Freezing Nerves to Relieve Pain from Rib Fractures
UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture, a Pilot Randomized Control Trial (UNPIN Trial)
This study is testing if freezing the nerves can help people with rib fractures feel less pain compared to a fake treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05865327 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with unilateral traumatic rib fractures who can undergo an ESP block catheter.
Not a fit: Patients with chronic pain, significant distracting injuries, or contraindications to the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve recovery for patients with rib fractures.
How similar studies have performed: While cryoneurolysis is a novel approach for rib fracture pain management, similar nerve freezing techniques have shown promise in other pain management contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.