Clinical trial NCT05415384: Randomized Control Trial, Cryoablation as an Adjunct to Surgical Stabilization of Rib Fractures
Official title: Single Center, Randomized Control Trial of Cryoablation During Surgical Stabilization of Rib Fractures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Rib Fracture Multiple
Keywords: Locoregional pain
thoracotomy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The proposed study is a single center, prospective, randomized controlled trial evaluating the efficacy of adding cryoneurolysis for patients that meet indication for Surgical Stabilization of Rib Fractures (SSRF) and consent to surgical fixation
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Morphine Milligram Equivalents Use following Intervention
timeFrame: Baseline
measure: Morphine Milligram Equivalents Use following Intervention
timeFrame: Day 1
measure: Morphine Milligram Equivalents Use following Intervention
timeFrame: Day 30
measure: Morphine Milligram Equivalents Use following Intervention
timeFrame: Day 90
Secondary outcomes:
measure: Number of days in Hospital Stay
timeFrame: Days during admission
measure: Number of days in ICU Stay
timeFrame: Day 90
measure: Amount of Chest tube drainage
timeFrame: Day 90
measure: Quality of Life Scores
timeFrame: Month 1 and Month 3
measure: Number of Mortalities in hospital
timeFrame: Day 90
measure: Number of Readmissions
timeFrame: 30 day readmission rate
measure: Number of Additional Thoracic Procedures
timeFrame: Day 7
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Bradely W. Thomas, MD
role: PRINCIPAL_INVESTIGATOR
References: