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

Rib Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04482582
• Other study ID #: 57099
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fractures

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Stanford Hospital and Clinics	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (36)

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	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.	Up to 1 month
Secondary	30-day mortality	Will be obtained from chart review after discharge	1 month
Secondary	Number of participants requiring ICU admission	Will be obtained from chart review after discharge	1 month
Secondary	Use of Narcotic Equivalents	Oral narcotic equivalents on day of discharge.	12 months
Secondary	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.	1 month
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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).	12 months