Intraoperative Cryoanalgesia for Pain Management After Sternotomy: A Randomized Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwestern University
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Average Daily Opioid Consumption in MME
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Cryoanalgesia
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).
Intervention: cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probe (Device)
Standard of Care (Control)
Patients in this arm will receive standard of care pain management alone.
Outcomes
Primary Outcomes
Average Daily Opioid Consumption in MME
Time Frame: 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 Outcomes
- Pain Quality(24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days)
- Pain Severity(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(during the first 48 hours postoperatively (starting upon ICU arrival))
- Quality of Recovery Score(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(24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days)
Investigators
Sawyer Naze
Assistant Professor of Anesthesiology
Northwestern University