RECRUITING

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

Conditions

Pain, Postoperative Rib Fracture Multiple Locoregional pain thoracotomy

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2022-08-01

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05415384

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.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Bradely W Thomas, MD

CONTACT

704-355-3176

bwthomas@wakehealth.edu

Principal Investigator

Bradely W. Thomas, MD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-01

Study Completion Date2025-09

Study Record Updates

Study Start Date2022-08-01

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

Locoregional pain
thoracotomy

Additional Relevant MeSH Terms

Pain, Postoperative
Rib Fracture Multiple