[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534014":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":40,"responsibleParty":58,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":26,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":26,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Ohio State University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pecto-intercostal fascial block","ACTIVE_COMPARATOR","Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine injected to each side under ultrasound visualization.",[13],"Procedure: Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Pecto-intercostal Fascial Block with 20ml of normal saline injected to each side under ultrasound visualization.",[19],"Procedure: Pecto-intercostal Fascial Block with normal saline",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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\u002Fallocation 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.",[9],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"Pecto-intercostal Fascial Block with normal saline",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Alberto A Uribe","CONTACT","6142930775","alberto.uribe@osumc.edu",{"name":37,"role":33,"phone":38,"phoneExt":26,"email":39},"Jeremy Reeves","6142933559","jeremy.reeves@osumc.edu",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"The Ohio State University Wexner Medical Center","RECRUITING","Columbus","Ohio","43210","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-82.99879,39.96118,{"lat":53,"lon":52},[56,57],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},{"name":37,"role":33,"phone":38,"phoneExt":26,"email":39},{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Erica Stein","Professor","100534014","sternotomy-pifb-block-in-open-heart-surgery-100534014",false,"NCT06233318","Sternotomy PIFB Block in Open Heart Surgery","Efficacy of Bilateral Pecto-Intercostal Fascial Plane Block on Postoperative Pain in Adult Patients Undergoing Open Heart Surgery: a Randomized, Double-blind, Controlled Trial","Inclusion Criteria:\n\n* Adult male or female patients aged \\> 18\n* Undergoing primary cardiac surgery requiring sternotomy\n* Able to provide a signed written informed consent\n* Able to speak, read, and write in English\n* American Society of Anesthesiologists (ASA) physical status I-IV\n\nExclusion Criteria:\n\n* Any documented cognitive or psychological disorders that, in the opinion of the principal investigator, can interfere with the patients' pain perception\n* Diabetes Mellitus with documented neuropathic pain\n* Vulnerable populations: pregnant females, prisoners, breast feeding\n* Contraindication to nerve block: local infections, bleeding disorders, chest wall deformity, allergy to local anesthetic or dexamethasone\n* Previous cardiac surgery\n* Previous history of chronic pain diseases requiring consistent analgesic therapy for at least 1 month prior to surgery\n* Presence of any medical condition that, in the opinion of the principal investigator, should exclude the patient from the study\n* BMI ≥ 40 kg\u002Fm2","ALL","18 Years",{"count":72,"type":73},84,"ESTIMATED","INTERVENTIONAL",[76],"NA","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.",[79],"Autonomic Nerve Block","2025-03-24",{"date":82,"type":83},"2025-03-27","ACTUAL",{"date":85,"type":83},"2023-10-16",{"date":87,"type":73},"2027-01-31",{"name":5,"class":6},1]