Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride

Study Overview
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Brief Summary
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The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) and compare it with bupivacaine hydrochloride infiltration

Detailed Description
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There are no studies to date on the use of LB infiltration and its analgesic efficacy in cardiac surgery done through sternotomy, even though the majority of cardiac surgeries utilize this approach. Moderate to severe pain is common in patients undergoing these surgeries and is usually inadequately treated. Other various pain treatment modalities such as opioid and neuraxial anesthesia are avoided due to potentially dangerous side effects in this cohort. The efficacy of local anesthesia techniques, such as bupivacaine, are limited due to short duration of action and increased incidence of wound infection. On the other hand, slow release liposomal bupivacaine may last up to 72 hours, indicating it's potential for more adequate analgesia compared to bupivacaine.

Official Title
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Postoperative Analgesia After Cardiac Surgery - A Double-Blind, Prospective and Randomized Comparison of Wound Infiltration With Liposomal Bupivacaine and Bupivacaine Hydrochloride

Conditions
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Coronary Artery Disease, Coronary Artery Stenoses, Valve Regurgitation, Mitral, Valve Regurgitation, Tricuspid

Intervention / Treatment
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* Drug: Exparel Injectable Product
* Drug: Bupivacaine Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Open cardiac surgery through sternotomy approach (eg. coronary artery bypass graft, valvular heart procedures, as well as other open cardiac procedures along with coronary artery bypass) Surgery with the use of cardiopulmonary bypass Exclusion Criteria: Minimally invasive heart surgery through thoracotomy approach Patient undergoing procedures under deep hypothermic circulatory arrest Patients with active infections such as infective endocarditis Emergency surgery Patients undergoing transplantations and ventricular assist device insertion Patients on any mechanical circulatory support preoperatively Patient's refusal End stage liver or renal disease Allergy to bupivacaine Patient who cannot understand the study procedure or refuse to participate Redo-sternotomy Participation in another study Patients with severe right or left ventricular dysfunction (EF< 25%) Patients requiring chronic opioids for chronic pain condition

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exparel Injectable Product<br>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group ( 30). | Drug: Exparel Injectable Product<br>* Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)<br>* Other names: Liposomal Bupivacaine;|
| Active Comparator: Bupivacaine Hydrochloride<br>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group ( 30). | Drug: Bupivacaine Hydrochloride<br>* Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)<br>* Other names: Bupivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Pain Intensity | Postoperative pain scores evaluated by numeric rating scale or (NRS) where 0- no pain and 10- worst pain, at rest and at movement | NRS scores will be evaluated every 4 hours until 24 hours post-operatively, every 8 hours until 48 hours post-operatively, and every 12 hours for 72 hours post-operatively | 
| Total Narcotic Consumption | All narcotics administered in the first 0-8, 8-24, 24-48, and 48-72 hours and the total narcotics administered in the 0-72 hours postoperative period(PCA narcotics, nurse-administered IV narcotics, and oral narcotics). All narcotics will be converted to total IV morphine equivalent for comparison between two groups. | 0-72 hours post-operative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Extubation | The time it takes until the patient is extubated post-operatively will be measured | From the end of surgery until the patient is extubated up to 72 hours post-operatively | 
| Patient Time to Mobilization | The time it takes until patient ambulates will be measured | From time of end of surgery to time of mobilization up to 72 hours or discharge, *assessed up to 120 hours* | 
| Patient Time to Out of Bed to Chair | The time it takes until the patient advances from bedrest to out of bed (OOB) to chair will be measured | From time of end of surgery to time of mobilization up to 72 hours post-operatively | 
| Patient Time to Oral Intake | The time it takes until the patient is able to/medically cleared to consume food or liquid will be measured | From time of end of surgery to time of oral intake up to 72 hours post-operatively or until hospital discharge | 
| Non-invasive Ventilation (NIV) Requirement | Episodes of NIV such as upper airway masks or similar devices will be quantified | From time of end of surgery to 72 hours post-operatively or until hospital discharge | 
| Re-intubation | Instances of re-intubation will be recorded | From time of end of surgery to patient discharge up to one week | 
| Use of Incentive Spirometry | Frequency of incentive spirometry will be measured | From time of end of surgery to 72 hours post-operatively | 
| Post-operative Nausea and Vomiting | Whether a patient experiences at least one episode of nausea and emesis will be measured | From time of end of surgery to 72 hours post-operatively | 
| Major Organ Dysfunction | Organ systems such as cardiac, renal, respiratory, and nervous system failure/dysfunction in accordance with the Society of Thoracic Surgeon's database will be noted | From date of surgery assessed up to 30 day post-operatively | 
| Length of Hospital and ICU Stay | Length of both hospital and ICU stay will be measured | From date of surgery assessed up to 30 day post-operatively | 
| Hospital Readmission | Readmission to hospital will be noted | From end of surgery assessed up to 30 days post-operatively | 
| Mortality | Mortality will be noted at specific timepoints | From end of surgery assessed up to 30 days post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, sternotomy, post-operative pain, sternal wound infiltration