CompletedPhase 4

Pecto-Intercostal Fascial Plane Block Study

United States100 participantsStarted 2022-03-28

Plain-language summary

This study is being done to see if bilateral pecto-intercostal fascial plane blocks (PIFB) with a mixture of liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). 100 participants will be recruited and can expect to be on study for 100 days.

Who can participate

Age range

18 Years – 80 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: * Participant provides consent to participate in study * Ideal body weight (IBW) is \>50kg * Participant is planned to undergo coronary artery bypass graft or single valve repair/replacement surgery via median sternotomy * Participant is undergoing an elective procedure Exclusion Criteria: * Participant is unable or unwilling to give consent * Non-English speaking * Known or believed to be pregnant or is currently breastfeeding * Participant is a prisoner * Clinically unstable per discretion of the Investigator * Participant requires urgent/emergent surgery * History of previous sternotomy * Preoperative coagulopathy (INR \>1.4, platelets \<100,000) or ongoing anticoagulation or anti-platelet therapy (except aspirin 81mg) * Allergy or sensitivity to amide-type local anesthetics, dexmedetomidine or ketamine * Participant has decompensated heart failure * Severe left ventricle dysfunction (defined quantitatively as an ejection fraction of less than or equal to 35%) or right ventricle dysfunction (defined qualitatively as "severe") * Diagnosis of cirrhosis or end-stage liver disease * Requires the use of mechanical circulatory support pre-operatively * Participant uses chronic opioids (meaning at the time of the preoperative screening evaluation by the study team, the patient is prescribed and taking any opioid pain medication)

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

Total Opioid Consumption 72 Hours Post-operatively

Timeframe: up to 72 hours post-operatively

Trial details

NCT IDNCT04928339

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-03

Results submitted2024-09-04

View on ClinicalTrials.gov More Cardiac Surgery trials