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Cryoneurolysis for Rib Fractures (UNPIN Trial)
N/A
Recruiting
Led By Ben Safa, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged ≥18
Unilateral traumatic rib fractures (3 to 8)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 post block procedure, and 1 week, 1 month and 3 month follow-ups
Awards & highlights
UNPIN Trial Summary
This trial will test if freezing nerves with a cold tool can reduce pain from broken ribs, compared to the usual methods.
Who is the study for?
This trial is for adults over 18 who've been admitted to the hospital within the last 48 hours with unilateral traumatic rib fractures (3 to 8 ribs). They must be candidates for a specific pain block catheter. People can't join if they have chronic pain, substance use disorders, certain medical conditions that prevent safe participation, or are unable to follow up after three months.Check my eligibility
What is being tested?
The study is testing cryoneurolysis—a technique using extreme cold to freeze nerves and reduce pain—against a sham procedure in patients with broken ribs from trauma. It aims to see if this method plus standard care works better than standard care alone in managing pain over three months.See study design
What are the potential side effects?
Potential side effects of cryoneurolysis may include temporary numbness or discomfort at the treatment site, skin changes due to cold exposure, and possible nerve damage although rare. The exact side effects will be monitored closely during the trial.
UNPIN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have between 3 to 8 broken ribs from an injury on one side.
UNPIN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 post block procedure, and 1 week, 1 month and 3 month follow-ups
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 post block procedure, and 1 week, 1 month and 3 month follow-ups
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants able to adhere to the follow-up
Number of participants able to adhere to the protocol
Number of participants randomized over an 8 month period
+1 moreSecondary outcome measures
Adverse events
ESP catheter use
Incidence of chronic rib fracture pain
+10 moreOther outcome measures
Pain Intensity
UNPIN Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cryoneurolysis GroupExperimental Treatment1 Intervention
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.
Group II: Standard Care GroupPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryoneurolysis
2018
N/A
~240
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,284 Total Patients Enrolled
1 Trials studying Rib Fractures
207 Patients Enrolled for Rib Fractures
Ben Safa, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
2 Previous Clinical Trials
84 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My BMI is over 45.I do not have major injuries that would prevent me from sitting up or lying on my side.I do not have conditions like cryoglobulinemia, cold hemoglobinuria, multiple myeloma, or cold urticaria.I am a candidate for an ESP block catheter procedure.My kidney function is reduced.I have between 3 to 8 broken ribs from an injury on one side.I can't go back to the Trauma Recovery Clinic after 3 months.I was admitted to the hospital within the last 48 hours.I don't have conditions that prevent ESP catheter placement.You have a problem with using drugs or alcohol.I cannot use self-controlled pain medication due to my condition.I take more than 30mg of pain medication daily.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Care Group
- Group 2: Cryoneurolysis Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Would I be eligible to join this experiment?
"Candidates must have sustained rib fractures and be between 18-100 years old to qualify for the study. 24 patients are needed in total."
Answered by AI
Is the enrollment of senior citizens part of this trial's protocol?
"In order to be accepted for inclusion in this trial, candidates must fall within the 18-100 age range. Separately, there are 337 clinical trials targeting minors and 1,674 studies geared towards seniors."
Answered by AI
Are any new participants being recruited for this clinical experiment?
"Per clinicaltrials.gov, this particular medical trial is no longer accepting candidates at the present time. It was initially published on June 1st 2023 and modified most recently on May 9th 2023. Despite not being an active participant in recruitment currently, there are still 2,074 other trials actively sourcing patients across the nation as of now."
Answered by AI
What is the ultimate aim of this venture?
"Over the 8-month trial period, researchers will track the ability of participants to adhere to protocol. Secondary objectives include evaluating time until ESP catheter discontinuation, total local anesthetic volume used through patient controlled regional analgesia (PCRA), and opioid consumption both during hospitalization and post-discharge measured in Oral Morphine Equivalents."
Answered by AI
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