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The proposed study is a randomized, double-blinded, non-placebo-controlled evaluation of the effect of the addition of dexamethasone to intraoperative intercostal nerve block bupivicaine solutions on the duration of pain relief and post operative pulmonary function.
Our study proposes two groups of 25 patients undergoing similar VATS surgery with a single surgeon, Dr. R. McKenna, who will receive interoperatively placed intercostal nerve blocks at the same levels. Each group will receive intercostals nerve blocks with one of two different solutions: group one will receive intercostal nerve blocks with only 0.46% bupivacaine (19.5 ml of 0.5% bupivacaine + .5 cc saline), group 2 will receive intercostal blocks with 0.46% bupivacaine and dexamethasone(19.5 ml of 0.5% bupivacaine + .5ml .4% dexamethasone). The patients will have pulmonary lung function objectively assessed by portable spirometry and clinical factors both preoperatively and postoperatively. Our study objective is to examine and quantify the potentially beneficial effects of intercostal nerve blockade prolongation with dexamethasone on postoperative pulmonary function and postoperative recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Placebo Comparator | an intercostal nerve block with a solution consisting of 0.46% bupivicaine (19.5 ml of 0.5% bupivicaine + .5ml normal saline) |
|
| Group 2 | Active Comparator | an intercostal nerve block with a solution consisting of 0.46% bupivicaine (19.5 ml of 0.5% bupivicaine + .5ml .4% dexamethasone) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine and Dexamethasone | Drug | The standard of care is to use a regional block solution containing both decadron and bupivicaine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post operative pain | Patients will be evaluated for post operative pain using the NRS pain evaulation | 72 hours post operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 11, 2015 | |
| Reset | May 27, 2015 | |
| Release | Jul 6, 2017 | |
| Reset | Jul 31, 2017 | |
| Release | Sep 7, 2017 | |
| Reset | Mar 29, 2018 | |
| Release | Jul 16, 2019 | |
| Reset | Aug 22, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 11, 2015 | May 27, 2015 | |||
| Jul 6, 2017 |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Placebo | Drug |
|
| Jul 31, 2017 |
| Sep 7, 2017 | Mar 29, 2018 |
| Jul 16, 2019 | Aug 22, 2019 |
| D000588 |
| Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |