Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy
Purpose
The ICE Study study will compare standard therapy (thoracic epidural) versus a novel approach (Cryoanalgesia combined with thoracic epidural) in subjects undergoing unilateral thoracotomy.
Conditions
- Chronic Post-thoracotomy Pain
- Acute Post-thoracotomy Pain
- Post-thoracotomy Pain Syndrome
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Control Arm |
Control Arm: Surgery without intercostal Cryoanalgesia + Standard of Care (thoracic epidural) |
|
Experimental Study Arm |
Study Arm: Surgery with intercostal Cryoanalgesia + Standard of Care (thoracic epidural) |
|
Recruiting Locations
Baltimore, Maryland 21201
More Details
- Status
- Unknown status
- Sponsor
- University of Maryland, Baltimore
Detailed Description
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.