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

AtriCure

Status: Completed

Conditions: Pain

Treatments: Drug: Standard of Care; Device: Cryoanalgesia

Study type: Interventional

Funder types: Industry

Identifiers

NCT02922153

CP2015-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

Cryoanalgesia + Standard of Care (SOC)

Experimental group

Description:

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

Treatment:

Device: Cryoanalgesia

Drug: Standard of Care

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Drug: Standard of Care