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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total narcotic use post-thoracotomy.

Timeframe: 6 months

Trial details

NCT IDNCT03538340

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

Contact for this trial

Melissa Culligan, RN, MS

410-328-6366 mculligan@som.umaryland.edu

View on ClinicalTrials.gov More Chronic Post-thoracotomy Pain trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.