Status:
COMPLETED
Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride
Lead Sponsor:
Kathirvel Subramaniam
Collaborating Sponsors:
Pacira Pharmaceuticals, Inc
Conditions:
Coronary Artery Disease
Coronary Artery Stenoses
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed 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. M...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03270514
Start Date
November 15 2018
End Date
February 25 2020
Last Update
September 5 2021
Active Locations (1)
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1
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213