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

Stanford University127 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

127

Conditions

Rib Fractures

Interventions

CryoneurolysisRADIATION

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.

Standard of CareOTHER

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford Hospital and Clinics

Palo Alto, California, United States

Outcomes

Primary Outcomes

Acute Pain Assessed by Numeric Pain Score

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.

Time frame: Hospital discharge (up to 1 month)

Secondary Outcomes

30-day Mortality

Will be obtained from chart review after discharge

Time frame: 1 month after hospital discharge

Number of Participants Requiring ICU Admission

Will be obtained from chart review after discharge

Time frame: 1 month after hospital discharge

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.

Time frame: Up to 1 month

Use of Narcotic Equivalents

Daily oral narcotic equivalents

Time frame: Hospital discharge (up to 1 month), 1 month, 3 months, 12 months after hospital discharge

Number of Participants With a Rib-specific Readmission Within 30 Days of Discharge

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 after hospital discharge

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 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.

Data from ClinicalTrials.gov

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