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

Not Applicable

Active, not recruiting

• Conditions: Rib Fractures
• Interventions: Radiation: Cryoneurolysis; Other: Standard of Care

• Registration Number: NCT04482582
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2020-07-18
• Study First Submitted QC: 2020-07-18
• Study First Posted: 2020-07-22
• Study Start: 2021-06-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Image-guided percutaneous ICN (pICN): Group A	Cryoneurolysis	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.
Standard-of Care : Group B	Standard of Care	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.

Primary Outcome Measures

Name	Time	Method
Acute Pain Assessed by Numeric Pain Score	12 months	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	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.

Secondary Outcome Measures

Name	Time	Method
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score	12 months	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	12 months	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.
Short Form (SF-12) Health Survey Scale Score	12 months	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).
30-day rib-specific readmission	1 month	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.
30-day mortality	1 month	Will be obtained from chart review after discharge
Number of participants requiring ICU admission	1 month	Will be obtained from chart review after discharge
Use of Narcotic Equivalents	12 months	Oral narcotic equivalents on day of discharge.

Trial Locations

Locations (1)

Stanford Hospital and Clinics; 🇺🇸 Palo Alto, California, United States