Early Percutaneous Cryoablation for Pain Control After Rib Fractures Among Elderly Patients
NCT ID: NCT04482582
Last Updated: 2024-05-16
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
110 participants
INTERVENTIONAL
2021-06-01
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Image-guided percutaneous ICN (pICN): Group A
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.
Cryoneurolysis
Patients will be offered a minimally invasive solution known as cryoneurolysis. By directly applying a cold cryoneurolysis probe to the nerves the axon is destroyed, resulting in Wallerian degeneration of the distal nerve without distorting epineurial or perineurial tissue. Application of cryoneurolysis will help reduce the amount of narcotics the patient would need to take and instead provide them longer term pain control with minimal risk.
Standard-of Care : Group B
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.
Standard of Care
Patients will be provided regular standard of care at the Stanford Hospital with long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.
Interventions
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Cryoneurolysis
Patients will be offered a minimally invasive solution known as cryoneurolysis. By directly applying a cold cryoneurolysis probe to the nerves the axon is destroyed, resulting in Wallerian degeneration of the distal nerve without distorting epineurial or perineurial tissue. Application of cryoneurolysis will help reduce the amount of narcotics the patient would need to take and instead provide them longer term pain control with minimal risk.
Standard of Care
Patients will be provided regular standard of care at the Stanford Hospital with long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.
Eligibility Criteria
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Inclusion Criteria
ii) Pain score equal to or greater than 5 with deep inspiration.
iii) Presenting and admitted to Stanford Emergency Department
Exclusion Criteria
ii) Glasgow Coma Scale (GCS) score \<13
iii) Patients undergoing SSRF
iv) Rib fractures located \< 3cm from spinous process
v) Coagulopathy (INR \>1.5, Pat \< 100)
vi) Other factors precluding cryoablation at IR attending's discretion
vii) If only ribs broken are 1,2 or 10,11, 12
65 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Joseph Forrester
Assistant Professor of Surgery
Principal Investigators
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Joseph D Forrester, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Nishita Kothary, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford Hospital and Clinics
Palo Alto, California, United States
Countries
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References
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Other Identifiers
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57099
Identifier Type: -
Identifier Source: org_study_id
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