Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy

Status unconfirmed · Not applicable

Conditions studied: Chronic Post-thoracotomy Pain, Acute Post-thoracotomy Pain, Post-thoracotomy Pain Syndrome

In brief

The ICE Study study will compare standard therapy (thoracic epidural) versus a novel approach (Cryoanalgesia combined with thoracic epidural) in subjects undergoing unilateral thoracotomy.

Key facts

Study ID

NCT03538340

Run by

University of Maryland, Baltimore

People needed

138

Starts

2018-09-01

Expected to finish

2023-01-31

Last updated by the study team

2021-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Maryland Medical Center — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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