[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537946":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":44,"locations":53,"responsibleParty":75,"collaborators":79,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":33,"eligibilityCriteria":86,"healthyVolunteers":83,"sex":87,"minAge":88,"maxAge":33,"enrollmentInfo":89,"targetDuration":33,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":56,"whyStopped":33,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Shriners Hospitals for Children","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"LB Treatment Arm","EXPERIMENTAL","Patients on the treatment arm will receive liposomal bupivacaine mixed with epinephrine (ratio of 1:100,000), which is not considered the standard of care.",[13,14],"Drug: Liposomal Bupivacaine","Drug: Epinephrine",{"label":16,"type":17,"description":18,"interventionNames":19},"Bupivacaine Control Arm","ACTIVE_COMPARATOR","Patients on the control arm will follow the current standard of care, which is traditional bupivacaine mixed with epinephrine (1:100,000).",[20,14],"Drug: Bupivacain",[22,29,34],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Liposomal Bupivacaine","Patients will receive liposomal bupivacaine mixed with epinephrine (ratio of 1:100,000) for pain management after surgery.",[9],[28],"EXPAREL",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Bupivacain","Patients will receive standard bupivacaine mixed with epinephrine (ratio of 1:100,000) for pain management after surgery.",[16],null,{"type":23,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Epinephrine","Patients will receive epinephrine (ratio of 1:100,000) mixed with the appropriate drug assigned to them based on their arm.",[16,9],[39],"Adrenalin",[41],{"name":42,"affiliation":5,"role":43},"Chad A. Purnell, MD","PRINCIPAL_INVESTIGATOR",[45,49],{"name":42,"role":46,"phone":47,"phoneExt":33,"email":48},"CONTACT","(724)-433-1645","cpurnell@shrinenet.org",{"name":50,"role":46,"phone":51,"phoneExt":33,"email":52},"Benjamin M. Smith, MS","(773) 385-5865","BenjaminM.Smith@shrinenet.org",[54],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Shriners Children's Chicago","RECRUITING","Chicago","Illinois","60707","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-87.65005,41.85003,{"lat":66,"lon":65},[69,73],{"name":70,"role":46,"phone":71,"phoneExt":33,"email":72},"Benjamin M Smith, MS","773-385-5865","benjaminm.smith@shrinenet.org",{"name":74,"role":43,"phone":33,"phoneExt":33,"email":33},"Chad A Purnell, MD",{"type":76,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"SPONSOR_INVESTIGATOR","Kerry O'Rourke","Clinical research coordinator",[80],{"name":5,"class":6},"100537946","phase-3-liposomal-bupivacaine-use-in-alveolar-bone-graft-patients-100537946",false,"NCT06284434","Liposomal Bupivacaine Use in Alveolar Bone Graft Patients","Inclusion Criteria:\n\n* Patients that are 6 and older who have a diagnosis of cleft lip and\u002For palate with a scheduled surgery that involves an alveolar bone graft.\n\nExclusion Criteria:\n\n* Patients under age 6 are excluded from this study as EXPAREL® is not FDA approved for this group.\n* Patients with a history of allergic or adverse reaction to any drug involved in the study (EXPAREL, Epinephrine, or Bupivacaine).\n* Patients with a history of cardiovascular disease.","ALL","6 Years",{"count":90,"type":91},60,"ESTIMATED","INTERVENTIONAL",[94],"PHASE3","The goal of this clinical trial is to learn if a pain medication called liposomal bupivacaine (brand name EXPAREL®) with epinephrine will provide better pain control, increased activity, and reduced use of opioids compared with the standard treatment for patients age 6 years and older with cleft lip and palate who have had an alveolar bone graft surgery. Investigators will look at:\n\n* pain scores at hip and jaw sites\n* opioid use in amount and frequency\n* scores on activity questionnaires Researchers will compare the results of these items with those of patients who had the standard treatment of bupivacaine with epinephrine.",[97],"Cleft Lip and Palate",[99,100,101,102,103],"cleft lip","cleft palate","alveolar bone graft","pain management","liposomal bupivacaine","2024-07-02",{"date":106,"type":107},"2024-07-03","ACTUAL",{"date":109,"type":107},"2024-04-24",{"date":111,"type":91},"2026-04-24",{"name":77,"class":6},1]