Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy
Unknown statusNot applicableNCT03538340
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The ICE Study study will compare standard therapy (thoracic epidural) versus a novel approach (Cryoanalgesia combined with thoracic epidural) in subjects undergoing unilateral thoracotomy.
Study details
- Official title
- Randomized, Single-Blinded, Controlled Trial Using Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy: ICE Study
- Conditions
- Chronic Post-thoracotomy Pain
- Acute Post-thoracotomy Pain
- Post-thoracotomy Pain Syndrome
- Interventions
- Procedure: Thoracic Epidural
- Procedure: Intercostal Cryoanalgesia
- Sponsor
- University of Maryland, Baltimore
- Collaborators
- AtriCure, Inc.
- Start date
- 2018-09-01
- Primary completion
- 2022-12-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03538340