Pain, Postoperative
Conditions
Brief summary
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.
Interventions
DEVICEcryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probe
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.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Opioid Consumption in MME | 48 hours | The average daily opioid consumption in morphine milligram equivalents (MME) during the first 48 hours postoperatively serves as the study's primary outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery Score | 48 hours/POD2 (post-operative day 2), 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days | Scale Title: Quality of Recovery Score Scale Values: 0 - 18 Higher score means a better outcome. |
| Patient Satisfaction with Pain Control Regimen | 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days | Scale Title: IPO (International Pain Outcomes) Questionnaire Scale Values: 0 - 320 Higher score means a worse outcome. |
| Pain Quality | 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days | Scale Title: IPO (International Pain Outcomes) Questionnaire Scale Values: 0 - 320 Higher score means a worse outcome. |
| Pain Severity | 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days | Scale Title: S-LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) Pain Score Scale Values: 0-24 Higher score means a worse outcome. |
| Average Daily Pain Scores | during the first 48 hours postoperatively (starting upon ICU arrival) | Scale Title: CPOT (Critical-Care Pain Observation Tool) Scale Values: 0-8 Higher score means a worse outcome. |
Countries
United States
Outcome results
None listed