Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy (NCT03538340) | Clinical Trial Compass
UnknownNot Applicable
Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy
United States138 participantsStarted 2018-09-01
Plain-language summary
The ICE Study study will compare standard therapy (thoracic epidural) versus a novel approach (Cryoanalgesia combined with thoracic epidural) in subjects undergoing unilateral thoracotomy.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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