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| Name | Class |
|---|---|
| AtriCure, Inc. | INDUSTRY |
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The researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. The research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal nerve block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intercostal nerve block | Active Comparator | Standard of care |
|
| Cryoablation | Experimental | Cryoablation is a procedure that is used to freeze and burn away tissue cells via a device called a cryosphere which emits a freezing gas. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atricure's crysoSPHERE probe | Device | Cryoablation is a procedure that is used to freeze and burn away tissue cells via a device called a cryosphere which emits a freezing gas. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of pain in the peri-operative period | Pain measured using a numeric rating scale ranging from 1-10 where a higher pain score indicates more pain severity | Post-op day 1 and day of hospital discharge, approximately 3 days |
| Inflammatory cytokine levels as measured by blood samples | Levels are measured using blood sample collection and assay specifically assessing IL-1, IL-6, TNF-a | Pre-surgery, 6-hours after end of surgery and 24-hours after surgery |
| Inflammatory cytokines (IL-1, IL-6, TNF-a) levels correlations to pain score | Correlations with the pain scores from outcome #1 | Pre-surgery, 6-hours after end of surgery and 24-hours after surgery |
| Peri-operative pain scores between different surgical incisions (posterolateral thoracotomy vs thoracoscopy) | Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity surveys | baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop |
| Peri-operative nerve function between different surgical incisions (posterolateral thoracotomy vs thoracoscopy) | assessment of feeling or touching sensations along the thoracic cavity measured using dermatone assessment | baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life score as measured by SF-36 Health questionnaire | 36 item survey instrument | baseline (prior to surgery), day of hospital discharge, approximately 3 days, 30-days, 90-days and 180-days post-op. |
| Cost (including postoperative epidural management, narcotic pain medication, and outpatient pain management) |
| Measure | Description | Time Frame |
|---|---|---|
| Complications following surgery | Any unexpected or unanticipated incidents, symptoms or medical issues following surgery | Up to 180-days following surgery |
| Length of stay | length of hospital stay |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shari L Barnett | Contact | 734-936-4561 | shbailey@umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rishindra Reddy, MD, MBA | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
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|
| Standard of Care | Procedure | An intercostal nerve block involves injecting anesthetic medications into nerves around the thoracic incision to provide temporary longer term pain relief after surgery. |
|
|
Hospital charges for cases that get standard of care postop pain management versus cases that receive cryoablation. |
| Up to 180-days postop |
| Workflow/time | Including items such as length of operating room use and length of hospital stay | Up to 180-days postop |
| Up to hospital discharge, approximately 3 days |
| Time to ambulation | Day of first ambulation documented | Up to 180-days following surgery |
| Chronic Pain medication use through 6 months | Up to 180-days after surgery |
| Chronic pain through 6 months. | Chronic pain is defined as pain that lasts for over three months as assessed by the PROMIS Pain Intensity survey | Up to 180-days after surgery |
| Chronic pain through 6 months. | Chronic pain is defined as pain that lasts for over three months as assessed by the PROMIS Pain Interference survey | Up to 180-days after surgery |
| Chronic pain through 6 months. | Chronic pain is defined as pain that lasts for over three months as assessed by the PROMIS Neuropathic Pain Quality Survey | Up to 180-days after surgery |
| Incentive spirometry volumes in the peri-operative period (POD 1 and 2) | Postop day 1 and 2 |
| Oxygen requirement | documentation of oxygen use | Up to 180-days postop |
| Hospital charges and hospital reimbursement by different payors | Up to 180-days postop |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |