The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)

Study Overview
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Brief Summary
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The investigators propose to assess whether intra-operative intercostal cryoanalgesia using the cryoICE® probe (AtriCure®, Inc., 7555 Innovation Way, Mason, Ohio) provides superior post-operative analgesic efficacy as compared to current pain management in patients undergoing unilateral thoracotomy cardiac procedures.

Detailed Description
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Completion of the proposed study will for the first time demonstrate efficacy of intercostal cryoanalgesia in patients undergoing minimally invasive cardiac procedures. Furthermore, results of this study may have a pivotal role in supporting future clinical outcome trials for intercostal cryoanalgesia therapy.

Official Title
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The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)

Conditions
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Pain

Intervention / Treatment
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* Device: Cryoanalgesia
* Drug: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 - 85 years male or female Patients undergoing unilateral thoracotomy cardiac procedures (with the exception of Aortic Aneurysm repair as sole treatment) Acceptable surgical candidate, including use of general anesthesia Willing and able to provide written informed consent Willing and able to return for scheduled follow-up visits Exclusion Criteria: Cardiac valve surgical procedure via conventional full sternotomy Procedures that require a posterolateral thoracotomy Current pregnancy Current use of prescription opioids FEV1 < 40% predicted Documented myocardial infarction within 30 days of signing Informed Consent Form (ICF) Documented psychiatric disease Documented chronic pain syndrome Documented history of substance abuse Patient currently enrolled in another research study that could directly affect results of either study Physical or mental condition that would interfere with patient's self-assessment of pain Disqualifying medical condition per investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryoanalgesia + Standard of Care (SOC)<br>Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session. | Device: Cryoanalgesia<br>* AtriCure® cryoICE cryo-ablation system<br>* Other names: cryoICE;Drug: Standard of Care<br>* Institutional SOC for pain management will be followed.<br>* Other names: SOC;|
| Active Comparator: Standard of Care<br>Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care. | Drug: Standard of Care<br>* Institutional SOC for pain management will be followed.<br>* Other names: SOC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome 1: Forced Expiratory Volume (FEV1) at 48-Hours Post-Surgery | Forced Expiratory Volume (FEV1) is the measurement of how much air, in volume, that a person can exhale with a forced breath. It is measured using a spirometer device. | 48-hours post-surgery | 
| Primary Outcome 2: Visual Analogue Scale (VAS) Pain in the Surgical Region at 48-Hours Post-Surgery | The Visual Analogue Scale (VAS) uses a picture of a linear scale that shows numbers 0-10 with 0 being the least amount of pain and 10 being the most amount of pain. This outcome looked at pain in the surgical region specifically. | 48-hours post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation | Spirometry assessments measured included: forced expiratory volume (FEV1), forced vital capacity (FVC) and slow vital capacity (SVC), all of which are measured with a spirometer. FEV1 is the amount of air forcibly expired during the first second of breath, FVC is the total volume of air expired over the whole forced breath and SVC is the total volume over the whole breath but at a slow pace, not forced. | 48-hours post-extubation | 
| Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points | The Visual Analogue Scale (VAS) uses a picture of a linear scale that shows numbers 0-10 with 0 being the least amount of pain and 10 being the most amount of pain. This outcome looked at pain in the surgical region specifically. | 72-, 96- and 120-hours Post-Op | 
| Secondary Outcome 3: Allodynia at the 3 and 6 Month Visit | Allodynia is pain around surgical site. It is pain that occurs from stimuli that are not normally painful such as a light touch or a brush of hair around where the surgery took place. | 3 and 6 Months | 
| Secondary Outcome 4: Duration of Oral Endotracheal Intubation From Extubation Until the Patient Leaves the Operating Room | Oral endotracheal intubation is where a patient has a tube placed down their throat and into the trachea, the large airway from the mouth to the lungs. This is done to ensure that patients who are asleep under anesthesia are able to fully breath. This outcome measured the hours from the time the patient leaves the operating room until they were extubated, or had the tube removed from their trachea. | Hours until patient is extubated from time patient leaves the operating room | 
| Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points | Patient Controlled Analgesia (PCA) is when the patient chooses to give themselves some form of analgesia, or painkiller, depending on their post-operation pain levels. Oral opioid consumption is the measure of all painkiller medicine that was prescribed by the hospital to the patient to take. This outcome measures each of these up to each time point and also measures the total PCA and oral opioid consumption post-procedure for the whole hospital stay. | 24-, 48, -96 and 120-hours | 
| Secondary Outcome 6: ICU and Hospital Length of Stay From Procedure to Discharge | The outcome measures the time spent in the intensive care unit (ICU) as well as the total hospital length of stay. | Procedure to Discharge | 
| Secondary Outcome 7: Ambulatory Movement During Hospital Stay | Ambulatory Movement, defined as the subjects ability to sit up, stand up, walk and flex both the left and right shoulders, was measured at multiple time points during hospital stay. | Baseline, 48, 72, 96, 120 Hours and Discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CryoAnalgesia, Thoracotomy, Forced Expiratory Volume (FEV1), Visual Analog Scale (VAS)