An interventional study of Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine and Pecto-intercostal Fascial Block with normal saline in Autonomic Nerve Block, sponsored by Ohio State University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
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.
Study design This is a single-center, prospective, randomized, placebo-controlled, double-blinded trial in patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center. All study procedures will be done in accordance with institutional and ORRP-IRB guidelines.
Study participants Adult patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center with an American Society of Anesthesiologists (ASA) physical status of I to IV who are scheduled to undergo open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center.
Sample size Eighty-four subjects who give written informed consent to participate in the study and who meet all inclusion and no exclusion criteria will be included in a single treatment group.
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Exclusion Criteria:
Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine injected to each side under ultrasound visualization.
Procedure: Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine
Pecto-intercostal Fascial Block with 20ml of normal saline injected to each side under ultrasound visualization.
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.
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.
OPIOID consumption at 24 hours
To compare the effect of bilateral PIFB on perioperative opioid consumption (MME) during the first 24 hours after surgery between groups
Time frame: 24 hours after block procedure
OPIOID consumption during surgery
To compare the amount of opioid consumption oral MME consumption during surgery between groups
Time frame: Surgery length
NRS pain score at 48 hours
To compare the NRS (0-10) pain score up to 48 hours
Time frame: Up to 48 hours after block procedure
Worst pain score at 48 hours
To compare the worst pain experienced during up to 48-hours after surgery between groups
Time frame: Up to 48 hours after block procedure
Incidence nausea and/or vomiting after surgery
To compare the incidence of nausea and/or vomiting up to 48-hours after surgery between both groups
Time frame: Up to 48 hours after block procedure
Self-reported satisfaction score at 48 hours
To compare self-reported patient satisfaction up to 48 hours after surgery between both groups
Time frame: 48 hours after block procedure
pain-DETECT scores at 90 days
To compare the "pain-DETECT" questionnaire scores prior to surgery (baseline) and 30 ± 7, 60 ± 7 and 90 ± 7 days after surgery between groups
Time frame: Up to 90 days after block procedure
Plan to share: Undecided — We estimate that a calculated sample size of 42 patients per group: PN ropivacaine and PN saline (control group)is required for a statistical power of 0.90 and a type I error of 0.05, to detect a 15% reduction (65 μg vs 55 μg, SD=13) in MME use between groups, accounting for 90% successful block rate and 10% of loss to follow-up; a total of 84 patients will be included. The primary outcome of mean MME of pain will be compared between the groups using a two-sample t-test or non-parametric equivalent. Continuous secondary outcomes will be analyzed using the same methods. Categorical secondary outcomes will be analyzed using Chi-square test/Fisher's Exact tests.
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