NCT06233318 · Ohio State University
Sternotomy PIFB Block in Open Heart Surgery
What this study 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 the usual treatment pain control regimen (called multimodal analgesia \[MMA\]), has a favorable effect on our institutional MMA pain regimen.
View original scientific description
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.
Interventions
PROCEDURE
Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine
The US probe will be placed at sagittal plane, 2 cm lateral to the midline of the sternum to identify the second to the fifth costal cartilage from the ribs. Consequently, the US probe will be positioned in the space between the fourth and fifth costal cartilages at the sternum. After identifying the fascial planes of the chest wall, the pectoralis major muscle (PMM), the external intercostal muscle (EIM), the costal cartilage, the pleura, and the lungs. A sterile 22G blunt Stimuplex, 50 mm needle (B. Braun, Bethlehem, Pa) will be advanced and placed under the PMM and above the EIM. Following negative aspiration, PN solution with investigational product according to group randomization/allocation will be injected at each side in 5 mL aliquots ensuring appropriate spread of the PN solution. The separation of the fascial plane and the spread of the drug will be observed on the ultrasound image in real time.
PROCEDURE
Pecto-intercostal Fascial Block with normal saline
The US probe will be placed at sagittal plane, 2 cm lateral to the midline of the sternum to identify the second to the fifth costal cartilage from the ribs. Consequently, the US probe will be positioned in the space between the fourth and fifth costal cartilages at the sternum. After identifying the fascial planes of the chest wall, the pectoralis major muscle (PMM), the external intercostal muscle (EIM), the costal cartilage, the pleura, and the lungs. A sterile 22G blunt Stimuplex, 50 mm needle (B. Braun, Bethlehem, Pa) will be advanced and placed under the PMM and above the EIM. Following negative aspiration, PN solution with investigational product according to group randomization/allocation will be injected at each side in 5 mL aliquots ensuring appropriate spread of the PN solution. The separation of the fascial plane and the spread of the drug will be observed on the ultrasound image in real time.
Primary outcome measures
OPIOID consumption at 24 hours
Time frame: 24 hours after block procedure
To compare the effect of bilateral PIFB on perioperative opioid consumption (MME) during the first 24 hours after surgery between groups
OPIOID consumption during surgery
Time frame: Surgery length
To compare the amount of opioid consumption oral MME consumption during surgery between groups
NRS pain score at 48 hours
Time frame: Up to 48 hours after block procedure
To compare the NRS (0-10) pain score up to 48 hours
Worst pain score at 48 hours
Time frame: Up to 48 hours after block procedure
To compare the worst pain experienced during up to 48-hours after surgery between groups
Incidence nausea and/or vomiting after surgery
Time frame: Up to 48 hours after block procedure
To compare the incidence of nausea and/or vomiting up to 48-hours after surgery between both groups
Self-reported satisfaction score at 48 hours
Time frame: 48 hours after block procedure
To compare self-reported patient satisfaction up to 48 hours after surgery between both groups
pain-DETECT scores at 90 days
Time frame: Up to 90 days after block procedure
To compare the "pain-DETECT" questionnaire scores prior to surgery (baseline) and 30 ± 7, 60 ± 7 and 90 ± 7 days after surgery between groups
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Columbus, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations