The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)

Pain Clinical Trial

— FROST  

Official title:

The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922153
• Other study ID #: CP2015-4
• Status: Completed
• Phase: N/A
• Start date: June 13, 2016
• Est. completion date: August 28, 2019

Study information

• Verified date: April 2020
• Source: AtriCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: August 28, 2019
• Est. primary completion date: March 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Cryoanalgesia
AtriCure® cryoICE cryo-ablation system

Drug:
• Standard of Care
Institutional SOC for pain management will be followed.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Southern California (USC)	Los Angeles	California
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	United Heart and Vascular Institute - Allina	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (11)

Cook TM, Riley RH. Analgesia following thoracotomy: a survey of Australian practice. Anaesth Intensive Care. 1997 Oct;25(5):520-4. — View 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. — View 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. — View 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. — View Citation

Katz J. Cryoanalgesia for postthoracotomy pain. Ann Thorac Surg. 1989 Jul;48(1):5. — View Citation

Loan WB, Dundee JW. The clinical assessment of pain. Practitioner. 1967 Jun;198(188):759-68. Review. — View 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. — View 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. — View Citation

PAPPER EM, BRODIE BB, ROVENSTINE EA. Postoperative pain; its use in the comparative evaluation of analgesics. Surgery. 1952 Jul;32(1):107-9. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome 1: Forced Expiratory Volume (FEV1) at 48-Hours Post-Surgery	Forced Expiratory Volume (FEV1) is the measurement of how much air, in volume, that a person can exhale with a forced breath. It is measured using a spirometer device.	48-hours post-surgery
Primary	Primary Outcome 2: Visual Analogue Scale (VAS) Pain in the Surgical Region at 48-Hours Post-Surgery	The Visual Analogue Scale (VAS) uses a picture of a linear scale that shows numbers 0-10 with 0 being the least amount of pain and 10 being the most amount of pain. This outcome looked at pain in the surgical region specifically.	48-hours post-surgery
Secondary	Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation	Spirometry assessments measured included: forced expiratory volume (FEV1), forced vital capacity (FVC) and slow vital capacity (SVC), all of which are measured with a spirometer. FEV1 is the amount of air forcibly expired during the first second of breath, FVC is the total volume of air expired over the whole forced breath and SVC is the total volume over the whole breath but at a slow pace, not forced.	48-hours post-extubation
Secondary	Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points	The Visual Analogue Scale (VAS) uses a picture of a linear scale that shows numbers 0-10 with 0 being the least amount of pain and 10 being the most amount of pain. This outcome looked at pain in the surgical region specifically.	72-, 96- and 120-hours Post-Op
Secondary	Secondary Outcome 3: Allodynia at the 3 and 6 Month Visit	Allodynia is pain around surgical site. It is pain that occurs from stimuli that are not normally painful such as a light touch or a brush of hair around where the surgery took place.	3 and 6 Months
Secondary	Secondary Outcome 4: Duration of Oral Endotracheal Intubation From Extubation Until the Patient Leaves the Operating Room	Oral endotracheal intubation is where a patient has a tube placed down their throat and into the trachea, the large airway from the mouth to the lungs. This is done to ensure that patients who are asleep under anesthesia are able to fully breath. This outcome measured the hours from the time the patient leaves the operating room until they were extubated, or had the tube removed from their trachea.	Hours until patient is extubated from time patient leaves the operating room
Secondary	Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points	Patient Controlled Analgesia (PCA) is when the patient chooses to give themselves some form of analgesia, or painkiller, depending on their post-operation pain levels. Oral opioid consumption is the measure of all painkiller medicine that was prescribed by the hospital to the patient to take. This outcome measures each of these up to each time point and also measures the total PCA and oral opioid consumption post-procedure for the whole hospital stay.	24-, 48, -96 and 120-hours
Secondary	Secondary Outcome 6: ICU and Hospital Length of Stay From Procedure to Discharge	The outcome measures the time spent in the intensive care unit (ICU) as well as the total hospital length of stay.	Procedure to Discharge
Secondary	Secondary Outcome 7: Ambulatory Movement During Hospital Stay	Ambulatory Movement, defined as the subjects ability to sit up, stand up, walk and flex both the left and right shoulders, was measured at multiple time points during hospital stay.	Baseline, 48, 72, 96, 120 Hours and Discharge