Pecto-intercostal fascial plane catheters (PIFB) for reduction of sternal pain after major cardiac surgery
The purpose of this study is to see if the PIFB works well for treating chest pain after open heart surgery. We hypothesize that continuous local anesthetic infusion (compared with placebo infusion) through bilateral PIFB catheters reduces acute sternal pain at 24 hours after cardiac surgery with complete median sternotomy.
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About the study
Principal investigator
Dr. Ron Ree
Cardiac and Regional Anesthesiologist
Area(s) of medical focus
Heart
Surgical
Condition(s)
Cardiopulmonary disease
Coronary artery disease
Heart valve disorders
Period of enrollment
2022-09-06 - 2024-09-06
Participating sites
St. Paul's Hospital
Purpose of trial
We have shown that a one-time PIFB works well for patients with very bad chest pain after heart surgery. Now, in this study, we want to see if a continuous infusion of freezing medication through PIFB for 48 hours will be even better.
We will insert two small plastic tubes (catheters), about the size of a vermicelli noodle, on either side of the patient's breastbone while they are asleep. These tubes will stay in place for 48 hours. We will infuse freezing medication through these small plastic tubes for 48 hours. We hope to show that by doing so, we can reduce pain for a longer time period than just the one-time PIFB.
No drugs are being tested in this study. Drugs (local anesthetic) will be used in this study, but they are not new, and not the subject of our study. This study will add freezing the nerves around the chest to the usual pain treatment.
This is a prospective, randomized, triple-blinded, placebo-controlled trial.
Eligibility
- English-speaking 19 years or older
- Scheduled cardiac surgery with complete median sternotomy
Contact information
Phone Number
Researcher
Co-Investigators
Dr. Tim Jen
Additional Information
Study Phase
Phase 4/ Post Market