Pectoral-Intercostal Fascial Plane Block Study (NCT03729635) | Clinical Trial Compass
CompletedNot Applicable
Pectoral-Intercostal Fascial Plane Block Study
Canada16 participantsStarted 2018-06-01
Plain-language summary
Pain along the sternum following opening of the chest cavity, also known as post-sternotomy pain (PSP), is a common complication after heart surgery that is associated with several negative side effects. Unfortunately, an effective and safe treatment has not yet been discovered for PSP. However, recently a regional anesthesia technique called the pecto-intercostal fascial block (PIFB) was found to be associated with improved pain relief for breast surgery. The investigators plan to assess the feasibility of using PIFB as an effective and safe treatment for PSP.
Who can participate
Age range
19 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:
* Patients undergoing a CABG and/or valve Surgery.
* Extubated and on no assisted ventilation
* NPRS equal to or greater than 5 related to sternal pain despite standard treatment
* Aged 19-80
* American Society of Anesthesiologists Physical Status Classification System 1 to 4 (ASA I-IV)
* Provided written informed consent
* Body Mass Index \< 35 kg/m\^2
* Patient weight equal to or greater than 50 kg
* CAM negative and RASS of +1 (restless) to -2 (light sedation)
Exclusion Criteria:
* A known history or allergy, sensitivity, or any other form of reaction to amide-type local anesthetics.
* Suspected inability to comply with study procedures, including language difficulties, or medical history and/or concomitant disease, as judged by the investigator.
* A neurological and/or vascular condition which may preclude eligibility for peripheral nerve blockade as judged by the investigator.
* Coagulopathy
* Previous inclusion in this study.
* Participation in other clinical studies during this study or in the 14 days prior to admission to this study.
* Neuromuscular disease
* Thoracotomy
* Mini-Sternotomy
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
Feasibility of PIFB in reduction of PSP following Sternotomy
Timeframe: Baseline to 30 minutes post-block completion