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Researchers hope to learn whether giving the longer-acting local anesthetic liposomal bupivacaine prior to closing the sternum is more effective in managing pain following sternotomy, than in patients who received standard bupivacaine before sternal closure. Researchers will measure this based on how much IV pain medication is used, rates on confusion, and time to remove the breathing tube.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal bupivacaine | Active Comparator | Exparel (266mg) given by surgeon just prior to sternal closure |
|
| Bupivacaine | Active Comparator | 40ml of 0.125% bupivacaine given by surgeon just prior to sternal closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug | The injections will be performed under direct guidance by the cardiac surgeon at bilateral sternal-costal interspaces 1.5 cm lateral the sternal boarder at levels 2-6 in divided doses (2 ml/injection) just before the closure of the sternum near the end of the surgical procedure. The final 20 ml will be injected into the skin incision after closure |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption in morphine equivalents | Opioid consumption in morphine equivalents | 0 hours post-surgery |
| Opioid consumption in morphine equivalents | Opioid consumption in morphine equivalents | 12 hours post-surgery |
| Opioid consumption in morphine equivalents | Opioid consumption in morphine equivalents | 24 hours post-surgery |
| Opioid consumption in morphine equivalents | Opioid consumption in morphine equivalents | 36 hours post-surgery |
| Opioid consumption in morphine equivalents | Opioid consumption in morphine equivalents | 48 hours post-surgery |
| Opioid consumption in morphine equivalents | Opioid consumption in morphine equivalents | 60 hours post-surgery |
| Opioid consumption in morphine equivalents | Opioid consumption in morphine equivalents | 72 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time to extubation in minutes will be retrieved via the electronic medical record | Time to extubation in minutes will be retrieved via the electronic medical record | 30 days post operative |
| Presence of sternal wound infection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angie Ballew, DC, MS | Contact | 9139457420 | aballew@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jared Staab, DO | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | 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 |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Bupivacaine | Drug | The injections will be performed under direct guidance by the cardiac surgeon at bilateral sternal-costal interspaces 1.5 cm lateral the sternal boarder at levels 2-6 in divided doses (2 ml/injection) just before the closure of the sternum near the end of the surgical procedure. The final 20 ml will be injected into the skin incision after closure |
|
Presence of sternal wound infection will be retrieved via electronic medical record and at 30 day follow up for Society of Thoracic Surgery (STS) database data as well as sternal infection documented at standard postoperative visit at 4-6 weeks
| 4-6 weeks postoperative visit |
| Postoperative delirium as assessed by Confusion Assessment Method (CAM)-ICU | Postoperative delirium as assessed by CAM-ICU at hours 0,12,24,36,48,60,and 72 hours post-surgery will be retrieved via the electronic medical record | 30 days post operative |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |