Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05415384

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Bradley W Thomas, MD

CONTACT

[email protected]

704-355-3176

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cryoablation of Intercostal Nerves

Device

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.

Standard surgical treatment of patients with multiple rib fractures

Procedure

Standard surgical treatment of patients with multiple rib fractures

Primary outcomes

  1. Morphine Milligram Equivalents Use following Intervention

    Time frame: Baseline

    To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.

  2. Morphine Milligram Equivalents Use following Intervention

    Time frame: Day 1

    To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.

  3. Morphine Milligram Equivalents Use following Intervention

    Time frame: Day 30

    To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.

  4. Morphine Milligram Equivalents Use following Intervention

    Time frame: Day 90

    To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.

Secondary outcomes

  1. Number of days in Hospital Stay

    Time frame: Days during admission

    Hospital Length of Stay

  2. Number of days in ICU Stay

    Time frame: Day 90

    ICU Length of Stay

  3. Amount of Chest tube drainage

    Time frame: Day 90

    Chest tube drainage

  4. Quality of Life Scores

    Time frame: Month 1 and Month 3

    Quality of Life questionnaire - Quality of life questionnaire consists of a set of survey questions that can be used to collect data related to an individual in particular and society in general on various parameters that determine their general quality of life

  5. Number of Mortalities in hospital

    Time frame: Day 90

    Mortality, in hospital

  6. Number of Readmissions

    Time frame: 30 day readmission rate

    Readmission

  7. Number of Additional Thoracic Procedures

    Time frame: Day 7

    Additional Thoracic Procedures

Study contacts

Contact information is provided by the study sponsor or research team.

Bradely W Thomas, MD

CONTACT

[email protected]

704-355-3176

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 13, 2022
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.