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Search / Trial NCT05865327

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

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · May 9, 2023

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Cryoneurolysis Rib Fracture Pain Intercostal Nerve Block

ClinConnect Summary

This clinical trial is looking at a new way to help manage pain for patients with traumatic rib fractures, which are painful injuries often caused by accidents. The study tests a technique called cryoneurolysis, where a small tool is used to freeze the nerves responsible for pain. The goal is to see if this method can provide better pain relief than traditional pain management alone. If the initial tests are successful, the researchers plan to expand the study to include more participants to get a clearer understanding of its effectiveness.

To participate in this trial, individuals need to be at least 18 years old and have a certain number of broken ribs (between 3 to 8) from a recent injury. They also need to be within 48 hours of being admitted to the hospital. Participants will be asked to keep track of their pain levels and any medications they take for three months after the procedure. This study is currently recruiting participants and aims to find a better way to help those suffering from rib fracture pain improve their quality of life.

Gender

ALL

Eligibility 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

About Sunnybrook Health Sciences Centre

Sunnybrook Health Sciences Centre is a leading academic health science organization located in Toronto, Canada, renowned for its commitment to advancing patient care through innovative research and education. As a prominent clinical trial sponsor, Sunnybrook integrates cutting-edge medical research with clinical practice, focusing on a wide range of health disciplines, including cancer care, trauma, and cardiovascular health. The center collaborates with various stakeholders, including academic institutions, healthcare providers, and industry partners, to facilitate the development of novel therapies and improve health outcomes. With a robust infrastructure and a dedicated team of researchers and clinicians, Sunnybrook plays a pivotal role in translating scientific advancements into tangible benefits for patients.

Locations

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Ben Safa, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported