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Sternotomy PIFB Block in Open Heart Surgery

RecruitingNAAges 18 Years - anyAllOhio State University
NCT06233318 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate if the use of a bilateral nerve block with a local anesthetic (ropivacaine), as part of a standard of care pain control regimen (called multimodal analgesia \[MMA\]), has a favorable effect on our institutional MMA pain regimen. Subjects will go through the following study procedures: review of medical history and medications subjects have taken within a month prior to surgery. Subjects will be randomly assigned to one of the two study groups (1:1) to receive either, an ultrasound-guided bilateral nerve block (called "Pecto-Intercostal Fascial Block \[PIFB\]") with ropivacaine or saline 0.9 solution, in addition to our institutional MMA regimen. A baseline line pain and nausea scores will be recorded before surgery. The block will be performed right after general anesthesia induction. The details about the surgery will be collected. Pain assessmen

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult male or female patients aged \> 18 * Undergoing primary cardiac surgery requiring sternotomy * Able to provide a signed written informed consent * Able to speak, read, and write in English * American Society of Anesthesiologists (ASA) physical status I-IV Exclusion Criteria: * Any documented cognitive or psychological disorders that, in the opinion of the principal investigator, can interfere with the patients' pain perception * Diabetes Mellitus with documented neuropathic pain * Vulnerable populations: pregnant females, prisoners, breast feeding * Contraindication to nerve block: local infections, bleeding disorders, chest wall deformity, allergy to local anesthetic or dexamethasone * Previous cardiac surgery * Previous history of chronic pain diseases requiring consistent analgesic therapy for at least 1 month prior to surgery * Presence of any medical condition that, in the opinion of the principal investigator, should exclude the patient from the study * BMI ≥ 40 kg/m2
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What it tests

  • Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine
  • Pecto-intercostal Fascial Block with normal saline
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Where

1 site
The Ohio State University Wexner Medical Center
Columbus, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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