Clinical trial NCT04482582: Early Percutaneous Cryoablation for Pain Control After Rib Fractures Among Elderly Patients
Official title: Early Percutaneous Cryoablation for Pain Control After Rib Fractures Among Elderly Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rib Fractures
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 110
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We are proposing a prospective, randomized trial evaluating efficacy of image-guided percutaneous intercostal cryoneurolysis (pICN) for pain control after traumatic rib fractures in persons \>=65 years. Eligible patients would be enrolled by the trauma service after consent or assent is obtained. Patients will be randomized to either pICN within 72 hours of presentation or existing standard-of-care.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide long-term pain control for elderly patients with rib fractures in order to minimize their risk of complications and return them to baseline functional capacity

Detailed description: The purpose of this study is to provide long-term pain control for elderly patients with rib fractures in order to minimize their risk of complications and return them to baseline functional capacity. In order to do this, we would offer a minimally invasive solution known as Cryoneurolysis. By directly applying cold Cryoneurolysis to the nerves, this can destroy nerve axons, resulting in Wallerian degeneration of the distal nerve without distorting epineural or perineurial tissue. The application of cryoneurolysis will help reduce the amount of narcotics the patient would need, and potentially lead to a better post-injury quality of life.

Eligibility criteria: Inclusion criteria:

i) Patients greater than 65 years with any acute rib fracture

ii) Pain score equal to or greater than 5 with deep inspiration.

iii) Presenting and admitted to Stanford Emergency Department

Exclusion criteria:

i) Radiographic evidence of metastasis to ribs

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

Primary outcomes:
measure: Acute Pain Assessed by Numeric Pain Score
timeFrame: 12 months
measure: Length of hospital stay
timeFrame: Up to 1 month
Secondary outcomes:
measure: 30-day mortality
timeFrame: 1 month
measure: Number of participants requiring ICU admission
timeFrame: 1 month
measure: Use of Narcotic Equivalents
timeFrame: 12 months
measure: 30-day rib-specific readmission
timeFrame: 1 month
measure: The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
timeFrame: 12 months
measure: The Glasgow Outcome Scale Extended (GOS-E) Score
timeFrame: 12 months
measure: Short Form (SF-12) Health Survey Scale Score
timeFrame: 12 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
affiliation: Stanford University
name: Joseph D Forrester, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Nishita Kothary, MD
role: PRINCIPAL_INVESTIGATOR
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