Clinical trial NCT02922153: The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)
Official title: The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: CryoAnalgesia
Thoracotomy
Forced Expiratory Volume (FEV1)
Visual Analog Scale (VAS)
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-04
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Completion of the proposed study will for the first time demonstrate efficacy of intercostal cryoanalgesia in patients undergoing minimally invasive cardiac procedures. Furthermore, results of this study may have a pivotal role in supporting future clinical outcome trials for intercostal cryoanalgesia therapy.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Primary Outcome 1: Forced Expiratory Volume (FEV1) at 48-Hours Post-Surgery
timeFrame: 48-hours post-surgery
measure: Primary Outcome 2: Visual Analogue Scale (VAS) Pain in the Surgical Region at 48-Hours Post-Surgery
timeFrame: 48-hours post-surgery
Secondary outcomes:
measure: Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation
timeFrame: 48-hours post-extubation
measure: Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points
timeFrame: 72-, 96- and 120-hours Post-Op
measure: Secondary Outcome 3: Allodynia at the 3 and 6 Month Visit
timeFrame: 3 and 6 Months
measure: Secondary Outcome 4: Duration of Oral Endotracheal Intubation From Extubation Until the Patient Leaves the Operating Room
timeFrame: Hours until patient is extubated from time patient leaves the operating room
measure: Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points
timeFrame: 24-, 48, -96 and 120-hours
measure: Secondary Outcome 6: ICU and Hospital Length of Stay From Procedure to Discharge
timeFrame: Procedure to Discharge
measure: Secondary Outcome 7: Ambulatory Movement During Hospital Stay
timeFrame: Baseline, 48, 72, 96, 120 Hours and Discharge
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California (USC)
state: California
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Saint Paul
country: United States
facility: United Heart and Vascular Institute - Allina
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: William Beaumont Hospitals
name: Wei Lau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Loan WB, Dundee JW. The clinical assessment of pain. Practitioner. 1967 Jun;198(188):759-68. No abstract available.
citation: 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.
citation: 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.
citation: Cook TM, Riley RH. Analgesia following thoracotomy: a survey of Australian practice. Anaesth Intensive Care. 1997 Oct;25(5):520-4.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.