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The purpose of this study is to determine if local intra-operative application of ZYNRELEF (topical medication) during shoulder replacement surgery improves pain control (as defined by opioid consumption after surgery) compared to the use of an interscalene block with catheter. This is a randomized clinical trial without blinding. Subjects will complete patient reported outcomes before and after surgery. Subjects will track their narcotic use, pain scores and pain satisfaction after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZYNRELEF | Active Comparator |
| |
| Interscalene block with continuous catheter pump | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zynrelef | Drug | ZYNRELEF |
| |
| Bupivacaine |
| Measure | Description | Time Frame |
|---|---|---|
| Narcotic consumption | Narcotic consumption measured in morphine equivalent units (MEU) | From surgery to two-weeks following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain management cost | Total cost of the interscalene single shot block plus Zynrelef compared to the cost of the block plus catheter with pain pump | Perioperative |
| Pain management administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Aleem, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000723006 | bupivacaine-meloxicam drug combination |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Drug |
Interscalene block with continuous catheter pump |
|
Time needed by the anesthesiologists to perform the blocks in both groups.
| Perioperative |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |