Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy

Study Overview
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Brief Summary
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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.

Official Title
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Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy

Conditions
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Pain Management, Sternotomy

Intervention / Treatment
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* Drug: Exparel
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults over the age of 18 who present for elective open heart surgery that requires a sternotomy. Exclusion Criteria: Urgent and emergency procedures, preexisting sternal infections, prior sternotomy, preexisting pain syndromes, current chronic home opioid use, anterior rib or sternal masses, allergy to any of the components of liposomal bupivacaine and plain bupivacaine.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liposomal bupivacaine<br>Exparel (266mg) given by surgeon just prior to sternal closure | Drug: Exparel<br>* 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<br>|
| Active Comparator: Bupivacaine<br>40ml of 0.125% bupivacaine given by surgeon just prior to sternal closure | Drug: Bupivacaine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |