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Cryoanalgesia for Rib Fractures
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Cryoneurolysis
- Group 2: Sham
- 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.
- 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
In what way is Cryoneurolysis typically employed by medical professionals?
"Cryoneurolysis is frequently employed to treat hypotension, and can also be utilized for unresponsive bradycardia, pupil dilation, as well as open angle glaucoma (OAG)."
Is it possible to enroll in this investigation currently?
"As detailed on clinicaltrials.gov, this study has concluded its recruitment phase and is no longer searching for new participants. This trial was first posted April 3rd 2020 and last edited November 28th 2022, but there are still 439 other trials that continue to accept volunteers at the present moment in time."
How many volunteers have enrolled in this research?
"Currently, this clinical trial is inactive and has not been updated since November 28th 2022. However, there are 349 trials actively recruiting patients with fractures or broken bones, as well as 90 additional studies seeking participants for cryoneurolysis treatments."
Is Cryoneurolysis a secure procedure for people to undergo?
"The safety of cryoneurolysis has been verified through Phase 4 trials, leading to a score of 3."
Have any prior investigations explored Cryoneurolysis?
"Currently, there are 90 ongoing Cryoneurolysis trials with 19 of these studies in the final phase. 128 medical facilities across Karachi and Sindh have opened their doors to researchers seeking more understanding about this treatment."
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