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



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/13/2018
Start Date:November 15, 2018
End Date:November 2019
Contact:Amy Monroe
Email:monroeal@upmc.edu
Phone:412-623-6382

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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

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

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.

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
We found this trial at
1
site
Pittsburgh, Pennsylvania 15213
Principal Investigator: Kathirvel Subramaniam, MD, MPH
Phone: 412-623-6382
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mi
from
Pittsburgh, PA
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