Early Percutaneous Cryoablation for Pain Control After Rib Fractures Among Elderly Patients (EPERC)

Stanford University

Status: Completed

Conditions: Rib Fractures

Treatments: Radiation: Cryoneurolysis; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04482582

57099

Details and patient eligibility

About

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

Full 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.

Enrollment: 127 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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127 participants in 2 patient groups

Image-guided percutaneous ICN (pICN): Group A

Experimental group

Description:

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.

Treatment:

Radiation: Cryoneurolysis

Standard-of Care : Group B

Active Comparator group

Description:

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.

Treatment:

Other: Standard of Care