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Randomized trial of intraoperative intercostal block with bupivacaine with epinephrine compared to lipossomal extended release bupivacaine.
Patients undergoing minimally invasive thoracic surgery will be randomized to receive 0.05% bupivacaine with 1:200,000 epinephrine (control group) or extended release lipossomal bupivacaine. Primary outcomes are postoperative pain measured by visual analog scale, amount of morphine equivalent narcotics used, and postoperative complications. Patients are excluded if they undergo open thoracotomy, or minimally invasive decortication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine with epinephrine | Active Comparator | Patients will receive intraoperative intercostal nerve block with bupivacaine |
|
| Lipossomal extended release bupivacaine | Experimental | Patients will receive intraoperative intercostal nerve block with lipossomal extended release bupivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine liposome | Drug |
| ||
| Bupivacaine / Epinephrine |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Pain assessment with Visual Analog Scale (VAS). This is a numeric pain scale widely used in healthcare that ranks pain from 0 (no pain) to 10 (unbearable pain). A pain score below 3 is considered good. | 3-5 days post op |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Any complication occuring in the first 90 days classified according to the Clavien-Dindo classification. | 90 days post op |
| Narcotic used | Amount of morphine equivalent dosage used in the postoperative period |
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Inclusion Criteria: Patients who will be undergoing minimally invasive thoracic surgery
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benny Weksler, MD | Contact | 901-448-2918 | bweksler@uthsc.edu | |
| Suzie Glass, RN | Contact | 901-448-2918 | Suzie.Glass@mlh.org |
| Name | Affiliation | Role |
|---|---|---|
| Benny Weksler, MD | University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methodist University Hospital | Recruiting | Memphis | Tennessee | 38104 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Drug |
|
| 3-5 days post op |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |