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| Name | Class |
|---|---|
| AtriCure, Inc. | INDUSTRY |
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The ICE Study study will compare standard therapy (thoracic epidural) versus a novel approach (Cryoanalgesia combined with thoracic epidural) in subjects undergoing unilateral thoracotomy.
The ICE Study is a single institution pilot study designed to compare standard therapy (i.e., thoracic epidural) versus a novel approach (i.e., Cryoanalgesia combined with thoracic epidural) to address the need for better management of acute and long-term pain in the general thoracic surgery patient population. The study's primary objective will be to demonstrate if the new intraoperative pain management approach [i.e., intercostal Cryoanalgesia in conjunction with thoracic epidural] provides superior short-term and long-term analgesia efficacy in patients undergoing unilateral thoracotomy as compared to the current institutional standard of care (i.e., thoracic epidural). Patients will be randomized in a 1:1 design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Active Comparator | Control Arm: Surgery without intercostal Cryoanalgesia + Standard of Care (thoracic epidural) |
|
| Study Arm | Experimental | Study Arm: Surgery with intercostal Cryoanalgesia + Standard of Care (thoracic epidural) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracic Epidural | Procedure | The control arm will receive standard of care pain management which includes a Thoracic Patient Controlled Epidural |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Quality of Life (SF-36) changes from baseline to 6-months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Culligan, RN, MS | Contact | 410-328-6366 | mculligan@som.umaryland.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joseph S Friedberg, MD | U Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Center | Recruiting | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013662 | Tea |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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| Intercostal Cryoanalgesia | Procedure | The study arm will receive standard of care pain management which includes a Thoracic Epidural plus Intraoperative Intercostal Cryoanalgesia |
|
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 |
| 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 |
| 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 |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |