CompletedPhase 3

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

United States60 participantsStarted 2018-11-15

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Post-operative Pain Intensity

Timeframe: NRS scores will be evaluated every 4 hours until 24 hours post-operatively, every 8 hours until 48 hours post-operatively, and every 12 hours for 72 hours post-operatively

Total Narcotic Consumption

Timeframe: 0-72 hours post-operative period

Trial details

NCT IDNCT03270514

SponsorKathirvel Subramaniam

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-13

Results submitted2021-05-05

View on ClinicalTrials.gov More Coronary Artery Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.