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Cryoanalgesia for Rib Fractures
Phase 4
Waitlist Available
Led By Brian M Ilfeld, MD, MS
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Having a total of 1-6 rib fractures at least 3 cm distal to the costo-transverse joint sustained within the previous 3 days (bilateral fractures are acceptable, but the total of the two sides combined must not exceed 6 fractures)
Accepting of a cryoneurolysis procedure
Must not have
Any patient unable to correctly perform incentive spirometry as this is the primary outcome measure
Possessing any contraindication specific to cryoneurolysis such as a localized infection at the treatment site, cryoglobulinemia, cold urticaria and Reynaud's Syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Summary
This trial is testing whether freezing the nerve near the rib fracture site can provide longer-term pain relief and improve pulmonary function compared to a sham procedure.
Who is the study for?
Adults over 18 with 1-6 recent rib fractures who want regional anesthesia can join this trial. It's not for those on opioids, pregnant, unable to communicate or follow instructions, with mental incapacity, flail chest, a chest tube, certain conditions like cold allergies or Reynaud's Syndrome, obesity (BMI >40), or severe pain from other causes.
What is being tested?
The study tests if cryoanalgesia—a technique that freezes nerves—can better manage pain and improve lung function in rib fracture patients compared to standard nerve blocks with local anesthetic. Participants are randomly assigned to receive either the freezing treatment or a sham procedure.
What are the potential side effects?
Cryoanalgesia might cause temporary numbness or skin changes at the site of application. There could also be discomfort during the procedure and risks associated with nerve freezing such as damage to surrounding tissues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have 1-6 rib fractures not near the spine, from the last 3 days.
Select...
I am willing to undergo a cryoneurolysis procedure.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I can correctly perform incentive spirometry.
Select...
I do not have infections, cryoglobulinemia, cold urticaria, or Reynaud's Syndrome at the treatment site.
Select...
My BMI is over 40.
Select...
I have been using opioids daily for more than 4 weeks.
Select...
I have multiple broken ribs causing chest instability.
Select...
I have a broken first rib.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Brief Pain Inventory
Brief Pain Inventory [partial]
Day of discharge
+5 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: CryoneurolysisActive Control1 Intervention
Active cryoneurolysis: 3 mL of normal SALINE will be injected into the muscle superficial to the nerve followed by an ACTIVE cryoneurolysis procedure using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
Group II: ShamPlacebo Group1 Intervention
Sham cryoneurolysis: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block followed by a SHAM cryoneurolysis procedure with a probe that vents the nitrous oxide prior to reaching the probe tip using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,136 Previous Clinical Trials
1,554,224 Total Patients Enrolled
Brian M Ilfeld, MD, MSPrincipal InvestigatorUniversity California San Diego
19 Previous Clinical Trials
1,521 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience pain above mild levels not related to my rib fractures.I can correctly perform incentive spirometry.I do not have infections, cryoglobulinemia, cold urticaria, or Reynaud's Syndrome at the treatment site.My doctor has requested a regional anesthetic for me.My BMI is over 40.I have been using opioids daily for more than 4 weeks.My doctor has concerns about my ability to make decisions.I am 18 years old or older.I have multiple broken ribs causing chest instability.You have a chest tube in place.I have 1-6 rib fractures not near the spine, from the last 3 days.I have a broken first rib.I am willing to undergo a cryoneurolysis procedure.
Research Study Groups:
This trial has the following groups:- Group 1: Cryoneurolysis
- Group 2: Sham
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
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