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

Kathirvel Subramaniam

Status and phase: Completed; Phase 3

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

Treatments: Drug: Bupivacaine Hydrochloride; Drug: Exparel Injectable Product

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03270514

PRO17060305

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Exparel Injectable Product

Experimental group

Description:

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).

Treatment:

Drug: Exparel Injectable Product

Bupivacaine Hydrochloride

Active Comparator group

Description:

Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).

Treatment:

Drug: Bupivacaine Hydrochloride