Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis

Stanford University43 enrolled

Overview

The purpose of this research study is to examine the effectiveness of using the Iovera Smart Time 190, for ultrasound-guided cryoneurolysis, in trauma patients 18-64 years old with rib fractures that are not candidates for surgical stabilization. This will offer patients the benefits of cryoneurolysis of the intercostal nerves, thereby providing short and long term pain control while their ribs heal. The Iovera Smart Tip 190 is FDA approved for cryoneurolysis.

The purpose of this research study is to examine the effectiveness of using the Iovera Smart Time 190, for minimally invasive ultrasound-guided cryoneurolysis, in trauma patients 18-64 years old with rib fractures that are not candidates for surgical stabilization. This procedure will offer patients the benefits of cryoneurolysis (freezing) of the intercostal nerves, thereby providing short and long term pain control while their ribs heal. Patients in the intervention arm will receive cryoneurolysis via the Iovera device and patients in the control arm will receive standard of care which typically includes multimodal pain therapy and pulmonary toilet. Short and long term pain relief will be compared among both arms.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rib Fractures

Interventions

Cryoneurolysis of Intercostal NervesDEVICE

Patients will be offered a minimally invasive intervention procedure for pain control called cryoneurolysis using an ultrasound-guided device called the Iovera Smart Tip 190. The direct application of cold to the intercostal nerves via Iovera device produces lesions in peripheral nervous tissue to block the pain caused by rib fractures. This procedure is particularly beneficial for patients who are not candidates for surgical stabilization of their rib fractures. Application of cryoneurolysis as an analgesic will reduce the amount of narcotics patients might need and instead provide them short- or long-term pain control with minimal risk. Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.

Standard of CareOTHER

Patients will be provided regular standard of care at the Stanford Hospital with short- or long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury. Standard of care for patients with rib fractures that are not eligible for surgical stabilization includes multi-modal pain therapy and pulmonary toilet. Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients 18 to 64 years with any acute rib fracture between rib 3 and rib 9 * Pain score equal to or greater than 5 with deep inspiration * Presenting and admitted to Stanford Adult Emergency Department, having a trauma consult, and being admitted to the trauma floors of Stanford Healthcare (SHC) for their inpatient stay Exclusion Criteria: * Radiographic evidence of metastasis to ribs * Glasgow Coma Scale (GCS) score \<13 * Patients undergoing SSRF (Surgical stabilization of rib fractures) * Rib fractures located \< 3cm from spinous process * Coagulopathy (INR \>1.5, Plt \< 100) * Other factors precluding cryoneurolysis at the attending's discretion * If only ribs broken are 1,2 or 10,11,12 * Inability to be positioned for the procedure * If the patient has the following conditions that the manufacturer of the Iovera device advises AGAINST using the device if present: Cryoglobulinemia, Paroxysmal cold hemoglobinuria, Cold urticaria, Raynaud's disease, open and/or infected wounds at or near the treatment site.

Locations (1)

Stanford Hospital and Clinics

Palo Alto, California, United States

Outcomes

Primary Outcomes

Daily Numeric Pain Score

Patients will be asked to verbalize their numeric pain score, measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain. Daily numeric pain score is collected on the day the patient is discharged from the hospital.

Time frame: At time of discharge from hospital (up to 1 month)

Secondary Outcomes

Daily Narcotic Equivalents

Morphine Milligram Equivalents (MME)

Time frame: Collected at discharge (up to 1 month), 1, 3, 12 months post discharge

Number of Patients With 30-day Mortality

Number of patients who died within 30 days of discharge, obtained from chart review.

Time frame: 1 month after hospital discharge

Need for ICU Admission

Will be obtained from chart review after discharge

Time frame: 1 month after hospital discharge

Number of Patients With a 30-day Rib-specific Admission

Patients with at least one rib-specific readmission (delayed hemothorax, pneumothorax, pneumonia, pain) within 30 days of discharge

Time frame: 1 month after hospital discharge

The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Sub Scores

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 during follow up. Using these questionnaires, McGill Present Pain Intensity (PPI), Sensory, Affective, and Visual Analogue Scale (VAS) sub 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. For all McGill pain scores, a higher score indicates a worse outcome.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.