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This study will assess analgesia after robotic lung surgery. Subjects will be randomized to receive wound infiltration and intercostal nerve block with either liposomal bupivacaine or bupivacaine/epinephrine + dexamethasone. Liposomal bupivacaine is a newer local anesthetic product and has not been compared to a combination of bupivacaine/epinephrine + dexamethasone in the context of pain control after robotic lung surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine/epinephrine + dexamethasone | Experimental |
| |
| Liposomal bupivacaine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intercostal nerve block and wound infiltration with liposomal bupivacaine | Drug | Intercostal nerve block and wound infiltration with liposomal bupivacaine during robotic lung resection surgery. 266mg of liposomal bupivacaine with 24 ml of 0.5% bupivacaine will be used. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale pain scores | Visual Analogue Scale (VAS) pain score will be assessed for non-inferiority of bupivacaine/epinephrine +dexamethasone vs. liposomal bupivacaine. A non-inferiority margin of 2 points on the VAS scale will be considered non-inferior. | 24 hours post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noud van Helmond, MD | Contact | 856-968-7336 | vanhelmond-noud@cooperhealth.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper University Hospital | Recruiting | Camden | New Jersey | 08103 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 26, 2024 | Apr 22, 2024 | 3 |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D004837 | Epinephrine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone | Drug | Intercostal nerve block and wound infiltration with liposomal bupivacaine during robotic lung resection surgery. 42 ml of 0.5% Bupivacaine/epinephrine with 8mg dexamethasone will be used. |
|
| 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 |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |