Actively Recruiting
Sternotomy PIFB Block in Open Heart Surgery
Led by Ohio State University · Updated on 2025-03-27
84
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 assessments, nausea and vomiting scores will be registered at 12, 24 and 48 hours after surgery as well. Lastly, a follow up phone call will be made by the research team to conduct a pain-detect questionnaire at 30, 60 and 90 days after surgery.
CONDITIONS
Official Title
Sternotomy PIFB Block in Open Heart Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Documented cognitive or psychological disorders affecting pain perception
- Diabetes Mellitus with documented neuropathic pain
- Pregnant females, prisoners, or breastfeeding individuals
- Contraindications to nerve block including local infections, bleeding disorders, chest wall deformity, allergy to local anesthetic or dexamethasone
- Previous cardiac surgery
- History of chronic pain diseases requiring consistent analgesic therapy for at least 1 month prior to surgery
- Any medical condition deemed exclusionary by the principal investigator
- Body mass index (BMI) ≥ 40 kg/m2
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
A
Alberto A Uribe
CONTACT
J
Jeremy Reeves
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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