The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)
Completed · Not applicable
Conditions studied: Pain
In brief
The investigators propose to assess whether intra-operative intercostal cryoanalgesia using the cryoICE® probe (AtriCure®, Inc., 7555 Innovation Way, Mason, Ohio) provides superior post-operative analgesic efficacy as compared to current pain management in patients undergoing unilateral thoracotomy cardiac procedures.
Key facts
- Study ID
- NCT02922153
- Run by
- AtriCure, Inc.
- People needed
- 84
- Starts
- 2016-06-13
- Expected to finish
- 2019-08-28
- Last updated by the study team
- 2020-09-04
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 - 85 years male or female
- Patients undergoing unilateral thoracotomy cardiac procedures (with the exception of Aortic Aneurysm repair as sole treatment)
- Acceptable surgical candidate, including use of general anesthesia
- Willing and able to provide written informed consent
- Willing and able to return for scheduled follow-up visits
You may not qualify if…
- Cardiac valve surgical procedure via conventional full sternotomy
- Procedures that require a posterolateral thoracotomy
- Current pregnancy
- Current use of prescription opioids
- FEV1 < 40% predicted
- Documented myocardial infarction within 30 days of signing Informed Consent Form (ICF)
- Documented psychiatric disease
- Documented chronic pain syndrome
- Documented history of substance abuse
- Patient currently enrolled in another research study that could directly affect results of either study
- Physical or mental condition that would interfere with patient's self-assessment of pain
- Disqualifying medical condition per investigator
Where it is running
- University of Southern California (USC) — Los Angeles, California, United States
- University of Michigan — Ann Arbor, Michigan, United States
- William Beaumont Hospital — Royal Oak, Michigan, United States
- United Heart and Vascular Institute - Allina — Saint Paul, Minnesota, United States
- Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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