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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05415384
• Other study ID #: IRB00084611
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: Bradely W Thomas, MD
• Phone: 704-355-3176
• Email: bwthomas[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Pain, Postoperative
• Rib Fracture Multiple
• Rib Fractures

Intervention

Device:
• Cryoablation of Intercostal Nerves
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.

Procedure:
• Standard surgical treatment of patients with multiple rib fractures
Standard surgical treatment of patients with multiple rib fractures

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Day 1
Primary	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.	Day 30
Primary	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.	Day 90
Secondary	Number of days in Hospital Stay	Hospital Length of Stay	Days during admission
Secondary	Number of days in ICU Stay	ICU Length of Stay	Day 90
Secondary	Amount of Chest tube drainage	Chest tube drainage	Day 90
Secondary	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	Month 1 and Month 3
Secondary	Number of Mortalities in hospital	Mortality, in hospital	Day 90
Secondary	Number of Readmissions	Readmission	30 day readmission rate
Secondary	Number of Additional Thoracic Procedures	Additional Thoracic Procedures	Day 7