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

Status:	Recruiting
Conditions:	Chronic Pain
Therapuetic Areas:	Musculoskeletal
Healthy:	No
Age Range:	18 - 85
Updated:	3/17/2019
Start Date:	June 2016
End Date:	August 2020
Contact:	Nfii Ndikintum, PhD, MBA
Email:	NNdikintum@AtriCure.com
Phone:	513-644-8192

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.

Inclusion Criteria:

- Patients undergoing unilateral thoracotomy cardiac procedures

- 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 IC

- Documented psychiatric disease

- Documented chronic pain syndrome

- Documented history of substance abuse

- Patient currently enrolled in another research study

- Physical or mental condition that could impact assessment of pain

- Disqualifying medical condition per investigator

We found this trial at

sites

University of Southern California (USC)

Los Angeles, California 90007

Principal Investigator: Vaughn Starnes, MD

Phone: 323-442-6226

from

Los Angeles, CA