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Completed
NCT05859061
Cryoanalgesia Study
Conditions: Pain, Postoperative
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 32
Sponsor: Northwestern University
Location: Northwestern University Chicago Illinois
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT05859061). StuddyBuddy aggregates publicly available trial information.