Post-thoracotomy Pain Syndrome Clinical Trial
— ICEOfficial title:
Randomized, Single-Blinded, Controlled Trial Using Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy: ICE Study
The ICE Study study will compare standard therapy (thoracic epidural) versus a novel approach (Cryoanalgesia combined with thoracic epidural) in subjects undergoing unilateral thoracotomy.
Status | Recruiting |
Enrollment | 138 |
Est. completion date | January 31, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland Medical Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore | AtriCure, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total narcotic use post-thoracotomy. | The primary outcome measure of this study is to determine if the addition of Cryoanalgesia to standard of care post thoracotomy pain control, results in decreased pain and/or narcotic use at time points ranging from perioperative to six months post discharge. | 6 months | |
Secondary | Visual Analog Scale (VAS) Assessment of post-thoracotomy pain | Visual Analog Scale will be used to assess pain levels (0-10 range scale with 0=no pain and 10= worse pain ever | 6 months | |
Secondary | Quality of Life (SF-36) changes from baseline to 6-months | Assessment of the impact of pain on quality of life (questions using varied assessment scales: rating general health from excellent to poor; yes-no; none to very severe; not at all to extremely; all of the time to none of the time; true-false | 6 months | |
Secondary | Allodynia Assessment | Allodynia screening and assessments will assess the levels of skin hypersensitivity associated with neuropathic pain following thoracotomy and will be performed at predetermined time points | 6 months | |
Secondary | Mankoski Pain Scale Assessment of post-thoracotomy pain | Mankoski Pain Scale will be used to assess pain levels (scale ranging from 0 to 10 with 0 = no pain to 10 = worse pain ever | 6 months |
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