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Did not receive funding
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The goals of this study are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single | Experimental | local anesthetic is delivered as a single bolus |
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| continuous | Active Comparator | local anesthetic is delivered as a continuous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine 0.25%-NaCl 0.9% Injectable Solution | Drug | 0.25% ropivacaine administered through a nerve catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | The maximum concentration of serum ropivacaine after pre-determined dose is delivered through the ESP nerve catheter | 28 hours |
| Tmax | The time elapsed from initial ropivacaine administration to Cmax | 28 hours |
| Area of analgesia | The area of numbness experienced in the chest wall; measured using a pinprick test and documented on a cartoon map showing a chest wall and dermatomal borders | 4 hours |
| Duration of analgesia | The duration of numbness to the chest wall; start time will be when the local anesthetic bolus is given, and end time will be when the participant reports the resolution of chest wall numbness | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bryant Tran, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2019 | Mar 7, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine 0.2%-NaCl 0.9% Injectable Solution | Drug | 0.2% ropivacaine administered through a nerve catheter |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |