[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651840":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":52,"collaborators":18,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":18,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":18,"enrollmentInfo":63,"targetDuration":18,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":75,"whyStopped":18,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Yale University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Acetaminophen delivery using the PCDD system","EXPERIMENTAL","Patient-controlled oral liquid acetaminophen delivery using the PCDD system in postoperative total shoulder replacement while inpatient.",[13],"Device: PCDD Generation 1 system",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard nurse-administered acetaminophen","NO_INTERVENTION","Participants will receive standard nurse-administered as-needed acetaminophen pills in postoperative total shoulder replacement while inpatient.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","PCDD Generation 1 system","Dispenses prescribed oral liquid medication through a secure, patient-activated mechanism . The system provides access to as needed oral liquid doses only within the prescribed dosing eligibility window.",[9],[26],{"name":27,"affiliation":5,"role":28},"Jinlei Li, MD PhD","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","475-434-4038","jinlei.li@yale.edu",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Daniel Wiznia, MD","(203) 785-2579","daniel.wiznia@yale.edu",[39],{"facility":40,"status":18,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":18},"Yale New Haven Hospital SRC","New Haven","Connecticut","06520","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-72.92816,41.30815,{"lat":50,"lon":49},{"type":53,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100651840","pcdd-generation-1-oral-liquid-acetaminophen-delivery-evaluation-100651840",false,"NCT07765238","PCDD Generation 1 Oral Liquid Acetaminophen Delivery Evaluation","Evaluation of the Patient-Controlled Dispenser & Deactivator (PCDD) Generation 1 System for Oral Liquid Acetaminophen Delivery","Inclusion Criteria:\n\nParticipants\n\n* Admitted to the participating orthopedic service for elective total shoulder replacement\n* Received a preoperative brachial plexus block\n* English speaking - as on-site study members are only fluent in English\n* Able to independently use the PCDD system and follow basic operating instructions\n\nNurses\n\n* Registered nurse employed at Yale New Haven Hospital.\n* Provides clinical care to an enrolled study participant during the participant's hospitalization.\n* Willing and able to provide informed consent.\n\nExclusion Criteria:\n\nParticipants\n\n* Patient refusal to participate\n* Pregnancy: all child bearing age patients will receive a urine screening test on the day of surgery and this result will be documented in the EMR epic. This is an elective procedure and the surgery will almost always be cancelled in the case of positive pregnancy test. In the extremely rare event the care proceeds, we will exclude the patient from the study. Emergency surgery\n* Cognitive impairment preventing informed consent or independent use of the device\n* Chronic pain requiring ongoing pain management or home opioid use\n* Substance use disorder\n* Failed preoperative brachial plexus block, defined as significant postoperative pain in the PACU requiring early escalation of analgesic management\n\nNurses\n\n* Declines or is unwilling to provide informed consent.","ALL","18 Years",{"count":64,"type":65},60,"ESTIMATED","INTERVENTIONAL",[68],"NA","This prospective randomized pilot study evaluates the feasibility, acceptability, and preliminary efficacy of the Patient-Controlled Dispenser and Deactivator (PCDD) Generation 1 system for patient-controlled oral liquid acetaminophen administration in postoperative total shoulder replacement inpatients compared with standard nurse-administered oral acetaminophen delivery.",[71,72],"Pain Management","Postoperative Pain",[74],"total shoulder replacement surgery","NOT_YET_RECRUITING","2026-08-10",{"date":78,"type":79},"2026-08-14","ACTUAL",{"date":81,"type":65},"2026-08",{"date":83,"type":65},"2027-12",{"name":5,"class":6},1]