Back to resultsRandomized Control Trial, Cryoablation as an Adjunct to Surgical Stabilization of Rib Fractures
Primary Purpose
Pain, Postoperative, Rib Fracture Multiple
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cryoablation of Intercostal Nerves
Standard surgical treatment of patients with multiple rib fractures
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Locoregional pain, thoracotomy
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 <72 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
Sites / Locations
- Wake Forest University Health SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy plus CRYOABLATION
Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy
Arm Description
Adding Cryoablation of levels 3-8, in addition to patients that undergo SSRF for multiple rib fractures.
Standard surgical treatment of patients with multiple rib fractures plus Multimodal Pain Therapy
Outcomes
Primary Outcome Measures
Morphine Milligram Equivalents Use following Intervention
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Morphine Milligram Equivalents Use following Intervention
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Morphine Milligram Equivalents Use following Intervention
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Morphine Milligram Equivalents Use following Intervention
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Secondary Outcome Measures
Number of days in Hospital Stay
Hospital Length of Stay
Number of days in ICU Stay
ICU Length of Stay
Amount of Chest tube drainage
Chest tube drainage
Quality of Life Scores
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
Number of Mortalities in hospital
Mortality, in hospital
Number of Readmissions
Readmission
Number of Additional Thoracic Procedures
Additional Thoracic Procedures
Full Information
NCT ID
NCT05415384
First Posted
June 6, 2022
Last Updated
June 27, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05415384
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Rib Fracture Multiple
Keywords
Locoregional pain, thoracotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
Participant
Masking Description
The study will blind patients to whether or not they underwent cryoneurolysis
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy plus CRYOABLATION
Arm Type
Experimental
Arm Description
Adding Cryoablation of levels 3-8, in addition to patients that undergo SSRF for multiple rib fractures.
Arm Title
Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy
Arm Type
Active Comparator
Arm Description
Standard surgical treatment of patients with multiple rib fractures plus Multimodal Pain Therapy
Intervention Type
Device
Intervention Name(s)
Cryoablation of Intercostal Nerves
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard surgical treatment of patients with multiple rib fractures
Intervention Description
Standard surgical treatment of patients with multiple rib fractures
Primary Outcome Measure Information:
Title
Morphine Milligram Equivalents Use following Intervention
Description
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Time Frame
Baseline
Title
Morphine Milligram Equivalents Use following Intervention
Description
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Time Frame
Day 1
Title
Morphine Milligram Equivalents Use following Intervention
Description
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Time Frame
Day 30
Title
Morphine Milligram Equivalents Use following Intervention
Description
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
Number of days in Hospital Stay
Description
Hospital Length of Stay
Time Frame
Days during admission
Title
Number of days in ICU Stay
Description
ICU Length of Stay
Time Frame
Day 90
Title
Amount of Chest tube drainage
Description
Chest tube drainage
Time Frame
Day 90
Title
Quality of Life Scores
Description
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
Time Frame
Month 1 and Month 3
Title
Number of Mortalities in hospital
Description
Mortality, in hospital
Time Frame
Day 90
Title
Number of Readmissions
Description
Readmission
Time Frame
30 day readmission rate
Title
Number of Additional Thoracic Procedures
Description
Additional Thoracic Procedures
Time Frame
Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 <72 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bradely W Thomas, MD
Phone
704-355-3176
Email
bwthomas@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradely W. Thomas, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bradley W Thomas, MD
Phone
704-355-3176
Email
bwthomas@wakehealth.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Randomized Control Trial, Cryoablation as an Adjunct to Surgical Stabilization of Rib Fractures
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