The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)
NCT ID: NCT02922153
Last Updated: 2020-09-04
Study Results
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View full resultsBasic Information
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COMPLETED
NA
84 participants
INTERVENTIONAL
2016-06-13
2019-08-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cryoanalgesia + Standard of Care (SOC)
Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.
Cryoanalgesia
AtriCure® cryoICE cryo-ablation system
Standard of Care
Institutional SOC for pain management will be followed.
Standard of Care
Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.
Standard of Care
Institutional SOC for pain management will be followed.
Interventions
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Cryoanalgesia
AtriCure® cryoICE cryo-ablation system
Standard of Care
Institutional SOC for pain management will be followed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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AtriCure, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Wei Lau, MD
Role: PRINCIPAL_INVESTIGATOR
William Beaumont Hospitals
Locations
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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
Countries
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References
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Sepsas E, Misthos P, Anagnostopulu M, Toparlaki O, Voyagis G, Kakaris S. The role of intercostal cryoanalgesia in post-thoracotomy analgesia. Interact Cardiovasc Thorac Surg. 2013 Jun;16(6):814-8. doi: 10.1093/icvts/ivs516. Epub 2013 Feb 19.
Moorjani N, Zhao F, Tian Y, Liang C, Kaluba J, Maiwand MO. Effects of cryoanalgesia on post-thoracotomy pain and on the structure of intercostal nerves: a human prospective randomized trial and a histological study. Eur J Cardiothorac Surg. 2001 Sep;20(3):502-7. doi: 10.1016/s1010-7940(01)00815-6.
Glauber M, Karimov JH, Farneti PA, Cerillo AG, Santarelli F, Ferrarini M, Del Sarto P, Murzi M, Solinas M. Minimally invasive mitral valve surgery via right minithoracotomy. Multimed Man Cardiothorac Surg. 2009 Jan 1;2009(122):mmcts.2008.003350. doi: 10.1510/mmcts.2008.003350.
Loan WB, Dundee JW. The clinical assessment of pain. Practitioner. 1967 Jun;198(188):759-68. No abstract available.
PAPPER EM, BRODIE BB, ROVENSTINE EA. Postoperative pain; its use in the comparative evaluation of analgesics. Surgery. 1952 Jul;32(1):107-9. No abstract available.
Katz J. Cryoanalgesia for postthoracotomy pain. Ann Thorac Surg. 1989 Jul;48(1):5. doi: 10.1016/0003-4975(89)90166-5. No abstract available.
Cook TM, Riley RH. Analgesia following thoracotomy: a survey of Australian practice. Anaesth Intensive Care. 1997 Oct;25(5):520-4.
SIMPSON BR, PARKHOUSE J, MARSHALL R, LAMBRECHTS W. Extradural analgesia and the prevention of postoperative respiratory complications. Br J Anaesth. 1961 Dec;33:628-41. doi: 10.1093/bja/33.12.628. No abstract available.
Maiwand MO, Makey AR, Rees A. Cryoanalgesia after thoracotomy. Improvement of technique and review of 600 cases. J Thorac Cardiovasc Surg. 1986 Aug;92(2):291-5.
Gough JD, Williams AB, Vaughan RS, Khalil JF, Butchart EG. The control of post-thoracotomy pain. A comparative evaluation of thoracic epidural fentanyl infusions and cryo-analgesia. Anaesthesia. 1988 Sep;43(9):780-3. doi: 10.1111/j.1365-2044.1988.tb05757.x.
Gwak MS, Yang M, Hahm TS, Cho HS, Cho CH, Song JG. Effect of cryoanalgesia combined with intravenous continuous analgesia in thoracotomy patients. J Korean Med Sci. 2004 Feb;19(1):74-8. doi: 10.3346/jkms.2004.19.1.74.
Lau WC, Shannon FL, Bolling SF, Romano MA, Sakwa MP, Trescot A, Shi L, Johnson RL, Starnes VA, Grehan JF. Intercostal Cryo Nerve Block in Minimally Invasive Cardiac Surgery: The Prospective Randomized FROST Trial. Pain Ther. 2021 Dec;10(2):1579-1592. doi: 10.1007/s40122-021-00318-0. Epub 2021 Sep 20.
Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CP2015-4
Identifier Type: -
Identifier Source: org_study_id
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