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

Description

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

Conditions

Pain, Postoperative, Rib Fracture Multiple

Study Overview

Study Details

Study 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

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

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

Condition
Pain, Postoperative
Intervention / Treatment

-

Contacts and Locations

Winston-Salem

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States, 27157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

Bradely W. Thomas, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

2025-09