Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy

The ICE Study is a single institution pilot study designed to compare standard therapy (i.e.,
thoracic epidural) versus a novel approach (i.e., Cryoanalgesia combined with thoracic
epidural) to address the need for better management of acute and long-term pain in the
general thoracic surgery patient population. The study's primary objective will be to
demonstrate if the new intraoperative pain management approach [i.e., intercostal
Cryoanalgesia in conjunction with thoracic epidural] provides superior short-term and
long-term analgesia efficacy in patients undergoing unilateral thoracotomy as compared to the
current institutional standard of care (i.e., thoracic epidural). Patients will be randomized
in a 1:1 design.

Inclusion Criteria:

- Patients undergoing unilateral thoracotomy for non-cardiac surgery

- Age 18-85 years of age; male or female

- 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:

- Prior major surgery within the last 6-months

- Documented psychiatric disease

- Documented chronic pain syndrome

- Current use of prescription opioids

- Documented history of substance abuse

- Functional disability or impairment (ECOG score = 0 or 1)

- Current pregnancy

- Patients 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

- A medical condition that in the investigator's opinion could adversely impact the
patient's participation or safety, conduct of the study or interferes with the pain
assessments