Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in C… (NCT04908449) | Clinical Trial Compass
CompletedPhase 1
Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery
United States62 participantsStarted 2023-06-19
Plain-language summary
The purpose of this study is to determine if ultrasound-guided bilateral pectointercostal fascial plane blocks with bilateral rectus sheath blocks block decrease pain scores, decrease opioid consumption, improve respiratory function, and improve quality of recovery in patients recovering from elective cardiac surgery involving primary median sternotomy and mediastinal chest tubes in comparison to pectointercostal fascial plane blocks alone.
Who can participate
Age range
18 Years – 85 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:
* Subjects scheduled for cardiac surgery involving primary median sternotomy and mediastinal chest tubes.
* Age 18-85 years of age
* BMI 18-50 kg/m2
* Weight \> 60 kg
Exclusion Criteria:
* Left ventricular ejection fraction (LVEF) \< 30%
* Preoperative, intraoperative, or immediate post-operative placement of intra-aortic balloon pump or deployment of extra-corporeal membrane oxygenation (ECMO)
* Inability to understand or speak English
* Allergy to bupivacaine or other amide local anesthetic
* Contraindication to peripheral nerve block (e.g. local infection, previous trauma to the block site)
* Chronic opioid consumption (daily oral morphine equivalent of \>20 mg) in the past three months
* Severe pulmonary or hepatic disease
* Neurological deficit or disorder
* Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past two years
* Uncontrolled anxiety, schizophrenia, or other severe psychiatric disorder
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
1
Pain Scores at Rest Within the First 24 Hours After Extubation
Timeframe: 24 hours after extubation
2
Pain Scores With Deep Breathing Within the First 24 Hours After Extubation