Cryoanalgesia Study
- Conditions
- Pain, Postoperative
- Interventions
- Device: cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probe
- Registration Number
- NCT05859061
- Lead Sponsor
- Northwestern University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 32
- Scheduled for elective CABG (coronary artery bypass graft) or single valve surgery via median sternotomy
- Reasonable expectation to be extubated within 24 hours postop
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cryoanalgesia cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probe 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).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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: Numeric Pain Rating Scale Scale Values: 0-10 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: 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: NRS (Numeric Rating Scale) Scale Values: 0-10 Higher score means a worse outcome.
Trial Locations
- Locations (1)
Northwestern University
🇺🇸Chicago, Illinois, United States