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

• Status: Completed
• Trial end date: 2020-02-25
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kathirvel Subramaniam
• Collaborator: Pacira Pharmaceuticals, Inc
• Treatments: Bupivacaine

Criteria

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