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

March 9, 2026 updated by: Joseph Forrester, Stanford University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Stanford Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Radiation: 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.
Active Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Pain Assessed by Numeric Pain Score
Time Frame: Hospital discharge (up to 1 month)

The patient will be asked to verbalize their numeric pain score on the day of hospital discharge. Pain is measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain.

Note: The timing of hospital discharge varies by patient as these are polytrauma patients.
Hospital discharge (up to 1 month)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of Narcotic Equivalents
Time Frame: Hospital discharge (up to 1 month), 1 month, 3 months, 12 months after hospital discharge
Daily oral narcotic equivalents
Hospital discharge (up to 1 month), 1 month, 3 months, 12 months after hospital discharge
The Glasgow Outcome Scale Extended (GOS-E) Score
Time Frame: 1 month, 3 months, 12 months (all from hospital discharge)

The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status into one of five categories: Dead, Vegetative State, Severe Disability, Moderate Disability or Good Recovery. The Extended GOS (GOSE) provides more detailed categorization into eight categories by subdividing the categories of severe disability, moderate disability and good recovery into a lower and upper category:

  1. Death (D)
  2. Vegetative state (VS)
  3. Lower severe disability (SD -)
  4. Upper severe disability (SD +)
  5. Lower moderate disability ( MD -)
  6. Upper moderate disability ( MD +)
  7. Lower good recovery (GR -)
  8. Upper good recovery (GR +)

The questionnaire will be administered to the patient by study/clinical staff upon discharge.
1 month, 3 months, 12 months (all from hospital discharge)
30-day Mortality
Time Frame: 1 month after hospital discharge
Will be obtained from chart review after discharge
1 month after hospital discharge
Number of Participants Requiring ICU Admission
Time Frame: 1 month after hospital discharge
Will be obtained from chart review after discharge
1 month after hospital discharge
Length of Hospital Stay
Time Frame: Up to 1 month
The Length of Stay will be obtained from the patient's chart after discharge and will depend on the level of care required for recovery from their injuries.
Up to 1 month
Number of Participants With a Rib-specific Readmission Within 30 Days of Discharge
Time Frame: 1 month after hospital discharge
The patient will be admitted back to the hospital if pain level relates to rib-specific injuries such as hemothorax and pneumonia.
1 month after hospital discharge
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
Time Frame: 1 month, 3 months, 12 months (all from hospital discharge)
The McGill Pain Questionnaire (MPQ) is a validated 20 question instrument to quantify subjective pain and the scoring system yields a Pain Rating Index (PRI) score between Mild, Moderate or Severe. The questionnaire will be administered to the patient by study/ clinical staff at 1-month, 3-month, and 12-month follow-ups. Using the questionnaires, McGill Present Pain Intensity (PPI), Sensory, Affective, and Visual Analogue Scale scores will be calculated and reported. PPI and Visual Analogue Scale scores are on a scale of 0-10, Sensory scores are on a scale of 0-33, and Affective scores are on a scale of 0-12. Higher scores indicate worse pain for all McGill scores.
1 month, 3 months, 12 months (all from hospital discharge)
Short Form (SF-12) Health Survey Scale Score
Time Frame: 1 month, 3 months, 12 months (all from hospital discharge)
The 12-Item Short-Form Health Survey is a widely used composite score used to gauge overall health. The composite score is based on 8 domains scores contained in the SF-12 questionnaire, which will be administered to the patient by study/clinical staff upon discharge. The composite score is split into two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Both scores are on a scale of 0-100, with higher scores representing better mental health-related (MCS) or physical health-related (PCS) quality of life. The means of both scores are standardized to 50 with a standard devation of 10.
1 month, 3 months, 12 months (all from hospital discharge)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Joseph D Forrester, MD, Stanford University
  • Principal Investigator: Nishita Kothary, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

April 25, 2024

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

July 18, 2020

First Submitted That Met QC Criteria

July 18, 2020

First Posted (Actual)

July 22, 2020

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 57099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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