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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)

Must not have

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))

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 post block procedure, and 1 week, 1 month and 3 month follow-ups

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have between 3 to 8 broken ribs from an injury on one side.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My BMI is over 45.

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I do not have major injuries that would prevent me from sitting up or lying on my side.

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I do not have conditions like cryoglobulinemia, cold hemoglobinuria, multiple myeloma, or cold urticaria.

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My kidney function is reduced.

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I can't go back to the Trauma Recovery Clinic after 3 months.

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I don't have conditions that prevent ESP catheter placement.

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I cannot use self-controlled pain medication due to my condition.

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I take more than 30mg of pain medication daily.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 post block procedure, and 1 week, 1 month and 3 month follow-ups for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

Adverse events

ESP catheter use

Incidence of chronic rib fracture pain

+10 more

Other study objectives

Pain Intensity

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

0 / 10Eligibility criteria met