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Cryoablation for Rib Fractures

N/A
Recruiting
Led By Bradely W. Thomas, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The patient is not being treated for chronic pain
The patient is >18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 1 and month 3
Awards & highlights

Study Summary

This trial compares two groups of patients, those who had surgery for broken ribs that included cryoablation, and those who had the same surgery without cryoablation. The study found that the group with cryoablation had better analgesia results.

Who is the study for?
This trial is for adults over 18 who have been admitted with multiple displaced rib fractures and are set to undergo surgical stabilization within 72 hours of injury. It's not for those under 18 or over 79, with severe brain injuries, spinal cord injuries, certain chest conditions like flail chest, major surgeries during this admission, inability to live independently before the injury, prisoners, pregnant women or if unable to perform VATS.Check my eligibility
What is being tested?
The study is testing whether using cryoablation (a technique that freezes nerves) along with standard surgery for broken ribs can provide better pain relief than surgery alone. Participants will be randomly assigned to either receive cryoablation plus surgery or just the surgery.See study design
What are the potential side effects?
Cryoablation may cause side effects such as local pain at the treatment site, skin numbness or tingling due to nerve changes. Standard surgical risks include infection risk and complications from anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not receiving treatment for chronic pain.
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I am older than 18 years.
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I have broken two or more ribs and agree to surgical repair.
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I am expected to have surgery within 3 days of my injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 1 and month 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 1 and month 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Morphine Milligram Equivalents Use following Intervention
Secondary outcome measures
Amount of Chest tube drainage
Number of Additional Thoracic Procedures
Number of Mortalities in hospital
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy plus CRYOABLATIONExperimental Treatment1 Intervention
Adding Cryoablation of levels 3-8, in addition to patients that undergo SSRF for multiple rib fractures.
Group II: Surgical Stabilization of Rib Fractures plus Multimodal Pain TherapyActive Control1 Intervention
Standard surgical treatment of patients with multiple rib fractures plus Multimodal Pain Therapy

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,234 Previous Clinical Trials
1,001,828 Total Patients Enrolled
Bradely W. Thomas, MDPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Standard surgical treatment of patients with multiple rib fractures Clinical Trial Eligibility Overview. Trial Name: NCT05415384 — N/A
Multiple Rib Fractures Research Study Groups: Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy plus CRYOABLATION, Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy
Multiple Rib Fractures Clinical Trial 2023: Standard surgical treatment of patients with multiple rib fractures Highlights & Side Effects. Trial Name: NCT05415384 — N/A
Standard surgical treatment of patients with multiple rib fractures 2023 Treatment Timeline for Medical Study. Trial Name: NCT05415384 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for participant recruitment in this medical investigation?

"Correct. As stated on clinicaltrials.gov, this medical trial initiated recruitment on August 1st 2022 and is actively searching for 80 individuals from a single location."

Answered by AI

What criteria must one fulfill in order to be eligible for participation in this research?

"Requirements for eligibility in this medical trial include being aged 18 or above, yet not exceeding 80 years old and having chronic pain. The research team is currently looking to recruit a total of 80 participants."

Answered by AI

Is eligibility for this research project confined to those aged 60 or older?

"According to the enrollment requirements, participants must be aged 18 or above but no older than 80 years."

Answered by AI

Is recruitment for this experiment still available to participants?

"Affirmative. Clinicaltrials.gov contains information that shows this clinical investigation is actively searching for individuals to partake in the study which was published on August 1st 2022 and revised on August 30th 2022. 80 participants are required from a single trial site."

Answered by AI
~7 spots leftby Jun 2024