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

Completed · Phase 3

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

In brief

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

Key facts

Study ID: NCT03270514
Run by: Kathirvel Subramaniam
People needed: 60
Starts: 2018-11-15
Expected to finish: 2020-02-25
Last updated by the study team: 2021-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

UPMC Presbyterian Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.