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| Name | Class |
|---|---|
| AtriCure, Inc. | INDUSTRY |
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This is a research study designed to test whether a treatment called Intercostal Nerve Cryotherapy is an effective way to help control post-surgical pain for patients undergoing minimally invasive pulmonary resection.
There are two treatment groups in this study, a cryotherapy group and control group. Cryotherapy is a method of controlling pain by freezing nerves between the ribs that would transmit pain impulses to the brain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoanalgesia with standard of care pain control | Experimental | subjects will receive standard of care pain control + cryoanalgesia in the intercostal spaces during routine surgery |
|
| Standard of care pain control | Active Comparator | subjects will receive standard of care pain control only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cryoanalgesia | Device | intraoperative intercostal nerve freezing for post-operative pain control |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine dose | total milligrams (mg) of morphine received during hospitalization | to discharge (up to 14 days) |
| Pain control | Pain level, as assessed by visual analog scale (rating 0-10), with 0 being no pain to 10 being worst pain, with higher scores meaning a worse outcome | to discharge (up to 14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| pulmonary complications | Pulmonary complications as defined by the Society of Thoracic Surgeons database | through 1 year |
| pain control | Pain level, as assessed by visual analog scale (rating 0-10), with 0 being no pain to 10 being worst pain, with higher scores meaning a worse outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AHN Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
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participants will be blinded to treatment group and will be sedated (part of standard of care surgery) at the time the treatment occurs
| Standard of Care Pain Control | Other | Standard of Care Pain Control Post-operatively |
|
| 2 weeks and 3 months post-operatively |
| total morphine equivalent dose of narcotics | total dose (e.g. milligrams) assessed by the number of pills taken by patients postoperatively | 2 weeks and 3 months post-operatively |
| Presence of neuropathy in the surgical site | physician will assess by modified treatment-induced neuropathy scale (0-10), with higher scores meaning a worse outcome; The modified questionnaire will assess the following symptoms and ask patients to score those symptoms from 0 (not present) to 10 (unbearable):
| 2 weeks, 3 months, 6 months and 1 year postoperatively |
| Incentive Spirometer Volume | The highest number (breath volume) achieved on exhalation using the incentive spirometer | to discharge (up to 14 days) |
| Hospital length of stay | Number of days spent in hospital postoperatively | to discharge (up to 14 days) |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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