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

Primary Purpose

Rib Fractures

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cryoneurolysis

Standard of Care

About this trial

This is an interventional treatment trial for Rib Fractures

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion:

Patients greater than 65 years with any acute rib fracture of ribs 3,4,5,6,7,8, or 9.
Pain score higher than or equal to 5
Presenting and admitted to Stanford Emergency Department

Exclusion:

Radiographic evidence of metastasis to ribs
Glasgow Coma Scale (GCS) score < 13
Patients undergoing Surgical Stabilization of Rib Fractures (SSRF)
Rib fractures located < 3cm from spinous process
Coagulopathy (INR >1.5, Pat < 100)
Other factors precluding cryoablation at Interventional Radiologist (IR) attending's discretion
Patients who do not have any rib fractures of ribs 3,4,5,6,7,8, or 9.

Sites / Locations

Stanford Hospital and ClinicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Image-guided percutaneous ICN (pICN): Group A

Standard-of Care : Group B

Arm 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.

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.

Outcomes

Primary Outcome Measures

Acute Pain Assessed by Numeric Pain Score

The patient will be asked to verbalize their numeric pain score daily after discharge and at follow-up visits. Pain measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain.

Length of hospital stay

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.

Secondary Outcome Measures

30-day mortality

Will be obtained from chart review after discharge

Number of participants requiring ICU admission

Will be obtained from chart review after discharge

Use of Narcotic Equivalents

Oral narcotic equivalents on day of discharge.

30-day rib-specific readmission

Incidence of readmission. The patient will be admitted back to the hospital if pain level relates to rib-specific injuries such as hemothorax and pneumonia.

The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score

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 upon discharge. The scoring system yields a pain rating index (PRI) score between 0 and 50 used to temporally track pain, higher scores correspond to higher pain levels.

The Glasgow Outcome Scale Extended (GOS-E) Score

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: Death (D) Vegetative state (VS) Lower severe disability (SD -) Upper severe disability (SD +) Lower moderate disability ( MD -) Upper moderate disability ( MD +) Lower good recovery (GR -) Upper good recovery (GR +) The questionnaire will be administered to the patient by study/clinical staff upon discharge.

Short Form (SF-12) Health Survey Scale Score

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. Score ranges from 1 (Excellent) to 5 (Poor) , 1 (Yes, limited a lot) to 3 (No, not limited at all), 1 (Yes) 2 (No), 1 (Not at all) to 5 (Extremely), 1 (All of the time) to 6 (None of the time) and 1 (All of the time) to 5 (None of the time).

Full Information

NCT ID

NCT04482582

First Posted

July 18, 2020

Last Updated

April 12, 2023

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT04482582

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rib Fractures

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Image-guided percutaneous ICN (pICN): Group A

Arm Type

Experimental

Arm Description

Arm Title

Standard-of Care : Group B

Arm Type

Active Comparator

Arm 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.

Intervention Type

Radiation

Intervention Name(s)

Cryoneurolysis

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Standard of Care

Intervention Description

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.

Primary Outcome Measure Information:

Title

Acute Pain Assessed by Numeric Pain Score

Description

The patient will be asked to verbalize their numeric pain score daily after discharge and at follow-up visits. Pain measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain.

Time Frame

12 months

Title

Length of hospital stay

Description

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.

Time Frame

Up to 1 month

Secondary Outcome Measure Information:

Title

30-day mortality

Description

Will be obtained from chart review after discharge

Time Frame

1 month

Title

Number of participants requiring ICU admission

Description

Will be obtained from chart review after discharge

Time Frame

1 month

Title

Use of Narcotic Equivalents

Description

Oral narcotic equivalents on day of discharge.

Time Frame

12 months

Title

30-day rib-specific readmission

Description

Incidence of readmission. The patient will be admitted back to the hospital if pain level relates to rib-specific injuries such as hemothorax and pneumonia.

Time Frame

1 month

Title

The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score

Description

Time Frame

12 months

Title

The Glasgow Outcome Scale Extended (GOS-E) Score

Description

Time Frame

12 months

Title

Short Form (SF-12) Health Survey Scale Score

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sydney Guthrie-Baker, BS

Phone

6507248445

sydneygb@stanford.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph D Forrester, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nishita Kothary, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford Hospital and Clinics

City

Palo Alto

State/Province

California

ZIP/Postal Code

94305

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

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

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