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.
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Day 180
Pain Quality
Pain Severity
Patient Satisfaction with Pain Control Regimen
48 hours
Average Daily Opioid Consumption in MME
Day 180
Quality of Recovery Score
Hour 48
Average Daily Pain Scores
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
2 Treatment Groups
Standard of Care (Control)
1 of 2
Cryoanalgesia
1 of 2
Active Control
Experimental Treatment
32 Total Participants · 2 Treatment Groups
Primary Treatment: Cryoanalgesia · No Placebo Group · N/A
Cryoanalgesia
Device
Experimental Group · 1 Intervention: cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probe · Intervention Types: DeviceStandard of Care (Control)NoIntervention Group · 1 Intervention: Standard of Care (Control) · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 hours/pod1 (post-operative day 1), 48 hours/pod2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,501 Previous Clinical Trials
866,531 Total Patients Enrolled
5 Trials studying Postoperative Pain
297 Patients Enrolled for Postoperative Pain
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
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- Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. doi: 10.1053/j.jvca.2011.08.001. Epub 2011 Sep 29. No abstract available.
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- Pala AA, Urcun YS, Cicek OF, Sahin S. Can Continuous Local Anesthetic Infusion After Median Sternotomy Reduce Opioid Use? Cureus. 2020 Sep 29;12(9):e10711. doi: 10.7759/cureus.10711.
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- Graves, Claire E., Jarrett Moyer, Michael J. Zobel, Roberto Mora, Derek Smith, Maura O'Day, and Benjamin E. Padilla. 2019. “Intraoperative Intercostal Nerve Cryoablation During the Nuss Procedure Reduces Length of Stay and Opioid Requirement: A Randomized Clinical Trial”. Journal of Pediatric Surgery. Elsevier BV. doi:10.1016/j.jpedsurg.2019.02.057.
- Park R, Coomber M, Gilron I, Shanthanna H. Cryoanalgesia for postsurgical pain relief in adults: A systematic review and meta-analysis. Ann Med Surg (Lond). 2021 Aug 5;69:102689. doi: 10.1016/j.amsu.2021.102689. eCollection 2021 Sep.
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- Anirban Sahu, MD, PhD 2023. "Cryoanalgesia Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05859061.
Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer