Clinical trial NCT05859061: Cryoanalgesia Study
Official title: Intraoperative Cryoanalgesia for Pain Management After Sternotomy: A Randomized Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Average Daily Opioid Consumption in MME
timeFrame: 48 hours
Secondary outcomes:
measure: Quality of Recovery Score
timeFrame: 48 hours/POD2 (post-operative day 2), 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
measure: Patient Satisfaction with Pain Control Regimen
timeFrame: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
measure: Pain Quality
timeFrame: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
measure: Pain Quality
timeFrame: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
measure: Pain Severity
timeFrame: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
measure: Pain Severity
timeFrame: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
measure: Average Daily Pain Scores
timeFrame: during the first 48 hours postoperatively (starting upon ICU arrival)
measure: Average Daily Pain Scores
timeFrame: during the first 48 hours postoperatively (starting upon ICU arrival)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
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