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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Reasonable expectation to be extubated within 24 hours postop
Scheduled for elective CABG (coronary artery bypass graft) or single valve surgery via median sternotomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours/pod1 (post-operative day 1), 48 hours/pod2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Awards & highlights
Study Summary
This trial will study the use of cold temperatures to reduce pain and opioid use in cardiac surgery patients. Results may provide an alternative to traditional pain control methods.
Who is the study for?
This trial is for patients scheduled for elective heart bypass or single valve surgery who can be taken off a ventilator within 24 hours after the operation. It's not suitable for those using opioids before surgery, pregnant or breastfeeding women, individuals unable to consent, those needing certain post-op support like ECMO, with chronic pain conditions, cold-related disorders, or previous chest surgeries.Check my eligibility
What is being tested?
The study tests cryoanalgesia—a technique that uses extreme cold to block nerve pain signals—using the cryoICE® system with CryoS probe in cardiac surgery patients. The goal is to see if this method reduces opioid use and hospital stay duration by effectively managing postoperative pain.See study design
What are the potential side effects?
Potential side effects may include localized numbness or discomfort at the treatment site due to nerve ablation from the cold temperatures used in cryoanalgesia. There might also be risks associated with skin and tissue reactions specific to cold sensitivity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am expected to breathe without a ventilator within 24 hours after surgery.
Select...
I am scheduled for heart bypass or valve surgery through a chest cut.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours/pod1 (post-operative day 1), 48 hours/pod2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours/pod1 (post-operative day 1), 48 hours/pod2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average Daily Opioid Consumption in MME
Secondary outcome measures
Average Daily Pain Scores
Pain Quality
Pain Severity
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CryoanalgesiaExperimental Treatment1 Intervention
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).
Group II: Standard of Care (Control)Active Control1 Intervention
Patients in this arm will receive standard of care pain management alone.
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,586 Previous Clinical Trials
917,219 Total Patients Enrolled
5 Trials studying Postoperative Pain
297 Patients Enrolled for Postoperative Pain
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Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current participant pool for this clinical trial?
"Affirmative. According to the clinicaltrials.gov archive, this medical study is currently recruiting participants, having been initially posted on April 10th 2023 and last updated on May 11th 2023. The trial requires 32 patients to be enrolled from 1 site location."
Answered by AI
Are recruitment opportunities still available for this investigation?
"According to clinicaltrials.gov, the search for patients is underway as of this writing. This medical trial was initially listed on April 10th 2023 and underwent its last edit on May 11th 2023."
Answered by AI
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