Cryoanalgesia Study

Study Overview
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Brief Summary
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This study will investigate the feasibility of cryoanalgesia in patients undergoing cardiac surgery via a median sternotomy. Cryoanalgesia is a technique that uses extremely cold temperatures to temporarily ablate nerves and block pain signals. Cryoanalgesia has been used for decades for pain control after thoracic surgery and has been associated with decreased opioid consumption, decreased pain scores, and shorter hospital stays. The results of this study may lead to a useful alternative for pain control in cardiac surgery patients.

Official Title
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Intraoperative Cryoanalgesia for Pain Management After Sternotomy: A Randomized Pilot Trial

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Device: cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for elective CABG (coronary artery bypass graft) or single valve surgery via median sternotomy Reasonable expectation to be extubated within 24 hours postop Exclusion Criteria: Prior history of surgery to the thorax (sternotomy, thoracotomy, thoracoscopy) Hemisternotomy approach History of cold urticaria, cryoglobulinemia, Raynaud's disease, or diabetic neuropathy Preoperative use of opioids History of chronic pain or associated syndromes Concurrent Cox maze procedure Need for post-bypass mechanical circulatory support (ECMO, IABP) or open chest Women who are pregnant or breastfeeding Patients who are unable to consent for themselves

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryoanalgesia<br>Intraoperative analgesic administration will be at the discretion of the anesthesia provider. Once adequate hemostasis is achieved and prior to sternal wire placement and chest closure, patients will undergo cryoablation of bilateral T2 - T6 intercostal nerves. The cryoprobe will be positioned under direct visualization and ablation of the intercostal nerve will be performed 2-4 cm lateral to the internal mammary artery near the mid-clavicular line. Each cryoablation at -50°C to -70°C will be applied for 120 seconds to sustain an ablation length of 2-3 cm at each intercostal nerve (bilateral T2 - T6). | Device: cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probe<br>* Per manufacturer instructions, the cryoprobe will be positioned under direct visualization and ablation of the intercostal nerve will be performed 2-4 cm lateral to the internal mammary artery near the mid-clavicular line. The study team plans to perform each cryoablation (-50°C to -70°C) for 120 seconds to sustain an ablation length of 2-3 cm at each intercostal nerve (bilateral T2 - T6). The probe will be removed after defrosting to avoid mechanical damage to the intercostal nerve. Cryoablation will be performed once hemostasis is achieved and prior to sternal wire placement and chest closure by a provider from the cardiac surgery team.<br>* Other names: Cryoablation;|
| No Intervention: Standard of Care (Control)<br>Patients in this arm will receive standard of care pain management alone. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Daily Opioid Consumption in MME | The average daily opioid consumption in morphine milligram equivalents (MME) during the first 48 hours postoperatively serves as the study's primary outcome. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery Score | Scale Title: Quality of Recovery Score Scale Values: 0 - 18 Higher score means a better outcome. | 48 hours/POD2 (post-operative day 2), 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days | 
| Patient Satisfaction with Pain Control Regimen | Scale Title: IPO (International Pain Outcomes) Questionnaire Scale Values: 0 - 320 Higher score means a worse outcome. | 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days | 
| Pain Quality | Scale Title: IPO (International Pain Outcomes) Questionnaire Scale Values: 0 - 320 Higher score means a worse outcome. | 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days | 
| Pain Quality | Scale Title: S-LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) Pain Score Scale Values: 0-24 Higher score means a worse outcome. | 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days | 
| Pain Severity | Scale Title: S-LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) Pain Score Scale Values: 0-24 Higher score means a worse outcome. | 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days | 
| Pain Severity | Scale Title: Numeric Pain Rating Scale Scale Values: 0-10 Higher score means a worse outcome. | 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days | 
| Average Daily Pain Scores | Scale Title: CPOT (Critical-Care Pain Observation Tool) Scale Values: 0-8 Higher score means a worse outcome. | during the first 48 hours postoperatively (starting upon ICU arrival) | 
| Average Daily Pain Scores | Scale Title: NRS (Numeric Rating Scale) Scale Values: 0-10 Higher score means a worse outcome. | during the first 48 hours postoperatively (starting upon ICU arrival) |