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Recruiting NCT05415384

Randomized Control Trial, Cryoablation as an Adjunct to Surgical Stabilization of Rib Fractures

No phase Interventional Pain, Postoperative Rib Fracture Multiple

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cryoablation of Intercostal Nerves, Standard surgical treatment of patients with multiple rib fractures.
Who it may be relevant to
Registry conditions: Pain, Postoperative, Rib Fracture Multiple. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Single Center, Randomized Control Trial of Cryoablation During Surgical Stabilization of Rib Fractures

Overview

To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of Surgical Stabilization of Rib Fractures (SSRF) without cryoablation

Detailed description

Locoregional pain control with cryoneurolysis of intercostal nerves has been employed as an adjunct for longer term pain control. Initially introduced in thoracic surgery, intercostal nerve cryoablation has demonstrated adequate pain control and substantial decrease in opioid consumption and hospital length of stay.

Interventions

  • Device Cryoablation of Intercostal Nerves
    Using Atricure device, cryoice, intercostal nerves 3-8 will be ablated in the experimental arm. This is in addition to mechanical fixation of rib fractures and multimodal systemic therapy.
  • Procedure Standard surgical treatment of patients with multiple rib fractures
    Standard surgical treatment of patients with multiple rib fractures

Primary outcome measures

  • Morphine Milligram Equivalents Use following Intervention [Time frame: Baseline]
  • Morphine Milligram Equivalents Use following Intervention [Time frame: Day 1]
  • Morphine Milligram Equivalents Use following Intervention [Time frame: Day 30]
  • Morphine Milligram Equivalents Use following Intervention [Time frame: Day 90]
Secondary outcome measures (7)
  • Number of days in Hospital Stay [Time frame: Days during admission]
  • Number of days in ICU Stay [Time frame: Day 90]
  • Amount of Chest tube drainage [Time frame: Day 90]
  • Quality of Life Scores [Time frame: Month 1 and Month 3]
  • Number of Mortalities in hospital [Time frame: Day 90]
  • Number of Readmissions [Time frame: 30 day readmission rate]
  • Number of Additional Thoracic Procedures [Time frame: Day 7]

Eligibility criteria

Inclusion criteria

  • The patient is admitted to the trauma service.
  • The patient has multiple displaced rib fractures (≥2 ribs), offered fixation, and consents to SSRF
  • The patient is not being treated for chronic pain
  • The patient is >18 years of age.
  • Surgery anticipated <120 hours from injury

Exclusion criteria

  • Age < 18 years or ≥ 80 years
  • Flail chest: either radiographic or clinical. Radiographic flail chest is defined on CT chest as ≥ 2 ribs each fractured in ≥ 2 places. Clinical flail is defined as visualization of a segment of chest wall with paradoxical motion on physical exam.
  • Moderate or severe traumatic brain injury (Intra-cranial hemorrhage visualized on CT head with GCS at the time of consideration for enrollment < 12)
  • Prior or expected emergency exploratory laparotomy during this admission
  • Prior or expected emergency thoracotomy during this admission
  • Prior or expected emergency craniotomy during this admission
  • Spinal cord injury
  • Pelvic fracture that has required, or is expected to require, operative intervention during this admission
  • The patient was unable to accomplish activities of daily living independently prior to injury (e.g., dressing, bathing, preparing meals)
  • The patient is incarcerated
  • The patient is known to be pregnant
  • Unable to perform Video Assisted Thoracoscopy (VATS) at time of SSRF due to lung isolation or previous pathology

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Wake Forest University Health Sciences — Winston-Salem

Identifiers

NCT: NCT05415384 · IRB00084611

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗