[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559118":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":38,"locations":48,"responsibleParty":81,"collaborators":42,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":42,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":42,"studyType":97,"phases":98,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":51,"whyStopped":42,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"University of Iowa","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","ACTIVE_COMPARATOR","Hydromorphone administered intravenous PCA combined with a continuous bupivacaine epidural infusion",[13],"Drug: Intravenous administered opioid",{"label":15,"type":10,"description":16,"interventionNames":17},"Treatment","Hydromorphone combined with bupivacaine in the epidural and administered as a continuous infusion with a PCEA bolus as necessary",[18],"Drug: Epidural administered opioid",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Intravenous administered opioid","Hydromorphone will be received intravenously using a patient controlled administration pump, as well as patient will have a continuous bupivacaine epidural infusion",[9],[26],"hydromorphone IV",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Epidural administered opioid","Hydromorphone will be added to the bupivacaine in the epidural and will have a continuous infusion along with the ability for the patient to receive epidural boluses of the medications by a patient controlled epidural administration pump",[15],[32],"Hydromorphone epidural",[34],{"name":35,"affiliation":36,"role":37},"Melinda Seering, MD","Univeristy of Iowa","PRINCIPAL_INVESTIGATOR",[39,44],{"name":35,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","3193848411",null,"Melinda-Seering@uiowa.edu",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Yair Rubin, MD","3193587989","yair-rubin@uiowa.edu",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"University of Iowa Health Care","RECRUITING","Iowa City","Iowa","52242","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-91.53017,41.66113,{"lat":61,"lon":60},[64,66,69,70,72,73,75,77,79],{"name":45,"role":40,"phone":65,"phoneExt":42,"email":47},"319-353-7211",{"name":67,"role":40,"phone":42,"phoneExt":42,"email":68},"Rakesh Sondekoppam Vijayashanka, MD","rakesh-sondekoppam@uiowa.edu",{"name":45,"role":37,"phone":42,"phoneExt":42,"email":42},{"name":67,"role":71,"phone":42,"phoneExt":42,"email":42},"SUB_INVESTIGATOR",{"name":35,"role":71,"phone":42,"phoneExt":42,"email":42},{"name":74,"role":71,"phone":42,"phoneExt":42,"email":42},"Adeeb Oweidat, MD",{"name":76,"role":71,"phone":42,"phoneExt":42,"email":42},"Anil Marian, MD",{"name":78,"role":71,"phone":42,"phoneExt":42,"email":42},"Sangini Punia, MD",{"name":80,"role":71,"phone":42,"phoneExt":42,"email":42},"Nada Sadek, MD",{"type":37,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Melinda Seering","Clinical Associate Professor","100559118","phase-2-iv-vs-epidural-opioids--epidural-local-anesthetic-for-laparotomy-analgesia-100559118",false,"NCT06559969","IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia","Randomized Controlled Study Comparing the Administration of Opioids Epidurally vs IV in Patients Undergoing Laparotomy With an Epidural for Post-Operative Analgesia","Inclusion Criteria:\n\n1. Age including and between 18 to 85 years old\n2. Planned open abdominal procedure with an incision that is or includes above the umbilicus, where epidural would normally be offered and epidural would be maintained for an average of 4 to 5 days\n3. Patient has consented for an epidural\n4. Patient is able to converse in English\n5. Patient is able to use a patient controlled pump\n\nExclusion Criteria:\n\n1. Has a known contraindication for an epidural\n2. Known mental or cognitive disability\n3. History of chronic opioid use or substance abuse disorder\n4. Pre-operative use of opioids\n5. History of chronic pain\n6. Routine use of marijuana\n7. Incarcerated\n8. Unable to converse in English\n9. Planned to remain intubated post-operatively\n10. Need for post-operative use of anticoagulant regiment that would be contraindicated with an indwelling epidural catheter\n11. End stage renal disease or dialysis\n12. Hepatic disease that affects metabolism of drugs\n13. Known contraindication to any of the study drugs\n14. Known pregnancy or positive pre-operative pregnancy test\n15. Known neurological condition that may affect motor or sensory systems","ALL","18 Years","85 Years",{"count":95,"type":96},80,"ESTIMATED","INTERVENTIONAL",[99,100],"PHASE2","PHASE3","The purpose of this research study is to determine if the two common ways of administering additional opioids (morphine like substance, narcotic) with an epidural, either mixed in the epidural solution or given separately through the intravenous, are equally effective in controlling post-operative pain",[103],"Laparotomy",[105,106,107,108,109,110,111],"Epidural","PCEA","PCA","Hydromorphone","bupivacaine","analgesia","laparotomy","2026-04-27",{"date":114,"type":115},"2026-04-28","ACTUAL",{"date":117,"type":115},"2024-09-17",{"date":119,"type":96},"2027-03-30",{"name":5,"class":6},1]