Recruiting at 1 site No phase Rib Fractures

Rib Fractures study: Cryoneurolysis

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

ClinicalTrials.gov ID: NCT05865327

What this study is testing

What it's testing
This study checks if it is possible to use a freezing tool to block pain nerves in people with broken ribs. It aims to see if this method works well before testing it in a larger group.
Who it's for
People who have broken ribs from an injury and are experiencing pain.
What's involved
Participants will have a procedure where a small tool freezes the nerves causing pain. They will also rate their pain and track any pain medicine they take.
Time commitment
The study involves tracking pain and medication for 3 months after the procedure.
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 100

You may be able to join if

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

You likely can't join 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
See the full eligibility criteria
Who can join
  • Aged ≥18
  • Unilateral traumatic rib fractures (3 to 8)
  • Candidate for ESP block catheter
  • Within 48hrs of admission to hospital
What rules you out
  • 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...
  • 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

The study team makes the final eligibility decision.

Where it is enrolling

  • Toronto, Ontario, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.