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

NCT02922153 | Completed Results FDA Device

• 1 other identifier: CP2015-4
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 5

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.

Conditions

Pain

Keywords

CryoAnalgesia; Thoracotomy; Forced Expiratory Volume (FEV1); Visual Analog Scale (VAS)

Outcome Measures

Primary Outcomes (2)

• 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 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 Outcomes (7)

• Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation

  48-hours post-extubation

• Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points

  72-, 96- and 120-hours Post-Op

• Secondary Outcome 3: Allodynia at the 3 and 6 Month Visit

  3 and 6 Months

• Secondary Outcome 4: Duration of Oral Endotracheal Intubation From Extubation Until the Patient Leaves the Operating Room

  Hours until patient is extubated from time patient leaves the operating room

• Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points

  24-, 48, -96 and 120-hours

Study Arms (2)

Cryoanalgesia + Standard of Care (SOC)

EXPERIMENTAL

Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.

Device: Cryoanalgesia; Drug: Standard of Care

Standard of Care

ACTIVE COMPARATOR

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.

Drug: Standard of Care

Interventions

Cryoanalgesia DEVICE

AtriCure® cryoICE cryo-ablation system

Also known as: cryoICE

Cryoanalgesia + Standard of Care (SOC)

Standard of Care DRUG

Institutional SOC for pain management will be followed.

Also known as: SOC

Cryoanalgesia + Standard of Care (SOC); Standard of Care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• AtriCure, Inc.: lead

Study Sites (5)

University of Southern California (USC)

Los Angeles, California, 90033, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

United Heart and Vascular Institute - Allina

Saint Paul, Minnesota, 55102, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (12)

• 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.

  PMID: 23424242 BACKGROUND

• 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.

  PMID: 11509270 BACKGROUND

• 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.

  PMID: 24415737 BACKGROUND

• Loan WB, Dundee JW. The clinical assessment of pain. Practitioner. 1967 Jun;198(188):759-68. No abstract available.

  PMID: 4859864 BACKGROUND

• 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.

  PMID: 14950594 BACKGROUND

• 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.

  PMID: 2764599 BACKGROUND

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

  PMID: 9352765 BACKGROUND

• 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.

  PMID: 13913200 BACKGROUND

• 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.

  PMID: 3736085 BACKGROUND

• 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.

  PMID: 3255292 BACKGROUND

• 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.

  PMID: 14966345 BACKGROUND

• 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.

  PMID: 34545530 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Nfii Ndikitum
• Organization: AtriCure

nndikintum@atricure.com

513-644-8192

Study Officials

• Wei Lau, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: October 4, 2016
• Study Start: June 13, 2016
• Primary Completion: March 4, 2019
• Study Completion: August 28, 2019
• Last Updated: September 4, 2020
• Results First Posted: September 4, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)