Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Location status: Recruiting
NCT Number: NCT05415384
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
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Winston-Salem, North Carolina, 27157, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Standard surgical treatment of patients with multiple rib fractures
Time frame: Baseline
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Time frame: Day 1
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Time frame: Day 30
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Time frame: Day 90
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Time frame: Days during admission
Hospital Length of Stay
Time frame: Day 90
ICU Length of Stay
Time frame: Day 90
Chest tube drainage
Time frame: Month 1 and Month 3
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: Day 90
Mortality, in hospital
Time frame: 30 day readmission rate
Readmission
Time frame: Day 7
Additional Thoracic Procedures
Contact information is provided by the study sponsor or research team.
Wake Forest University Health Sciences
Other
Single Center, Randomized Control Trial of Cryoablation During Surgical Stabilization of Rib Fractures
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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