[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596807":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":33,"locations":38,"responsibleParty":55,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":25,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":25,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University of Toronto","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intrathecal Morphine","ACTIVE_COMPARATOR","Adductor canal block; IPACK block; Spinal anesthesia: Isobaric Bupivacaine 0.5% 2.5 mL + Fentanyl 15 mcg + Morphine 100 mcg",[13],"Drug: Intrathecal Morphine",{"label":15,"type":16,"description":17,"interventionNames":18},"No Intrathecal Morphine","EXPERIMENTAL","Adductor canal block; IPACK block; Spinal anesthesia: Isobaric Bupivacaine 0.5% 2.5 mL + Fentanyl 15 mcg",[19],"Drug: No Intrathecal Morphine",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Intrathecal morphine",[9],null,{"type":22,"name":15,"description":15,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"affiliation":31,"role":32},"Hermann dos Santos Fernandes, MD, PhD","Department of Anesthesia and Pain Management, Mount Sinai Hospital Assistant","PRINCIPAL_INVESTIGATOR",[34],{"name":30,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","416-586-5270","hermann.dossantosfernandes@sinaihealth.ca",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Mount Sinai Hospital","RECRUITING","Toronto","Ontario","M5G 1X5","Canada","CA",{"type":48,"coordinates":49},"Point",[50,51],-79.39864,43.70643,{"lat":51,"lon":50},[54],{"name":30,"role":35,"phone":36,"phoneExt":25,"email":37},{"type":32,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Hermann dos Santos Fernandes","Assistant Professor","100596807","phase-3-post-operative-urinary-retention-on-revision-knee-arthroplasty-the-role-of-intrathecal-morphine-100596807",false,"NCT07050277","Post-Operative Urinary Retention on Revision Knee Arthroplasty: the Role of Intrathecal Morphine","POURRKA","Inclusion Criteria:\n\n* Non pregnant patients undergoing unilateral non infected rTKA surgery;\n* Older than 21 years of age, with American Society of Anesthesiologists (ASA) physical status I-III;\n* With no alcohol or drug dependency history;\n* With sufficient understanding and co-operation about the usage of a perineural catheter for pain management; body mass index (BMI) under 45;\n* With no allergy to medications used in the study protocol (bupivacaine, lidocaine, ropivacaine, midazolam, propofol, ketamine, morphine, hydromorphone, fentanyl, acetaminophen, celecoxib, ondansetron, dexamethasone, tranexamic acid);\n* No current or recent use of opioids (within the last 2 weeks) in an average oral morphine equivalent (OME) of 20 mg\u002Fday or higher;\n* With no contra-indications for neuraxial anesthesia, IPACK block, ACB and adductor canal catheter insertion;\n* Who speak and understand the English language;\n* Who agrees to participate on this study through the signature of the consent form.\n\nExclusion Criteria:\n\n* Patients will be excluded of the study if they have a failed spinal anesthesia and needs for a conversion to general anesthesia;\n* If peripheral nerve blocks are not possible to be performed due to technical difficulties;\n* If during patient's care a deviation of the protocol occurs;\n* If CACB catheter has issues on its function, disconnects or exteriorizes within the first 48 hours of infusion;\n* Or if patient decides to withdraw from the study.",true,"ALL","21 Years",{"count":69,"type":70},50,"ESTIMATED","INTERVENTIONAL",[73],"PHASE3","Revision total knee arthroplasty (rTKA) is a frequently performed procedure. Adequate pain management is an important feature, especially for fast-track and Enhanced Recovery After Surgery (ERAS) programs. The multimodal approach, including single shot or continuous nerve blocks with catheters and spinal or epidural morphine, is a stablished strategy. Although the administration of intrathecal morphine (IM) has been shown to significantly reduce pain scores, it is not free of adverse effects. Postoperative urinary retention (POUR) is possible and might increase the risk of periprosthetic infection. The purpose of this study is to compare patients undergoing rTKAS under spinal anesthesia with IM to patients undergoing the same procedure, under the same anesthetic technique, but with no IM, for POUR and postoperative pain related outcomes. All patients will have single shot and continuous adductor canal block (CACB) and single shot IPACK (interspace between the popliteal artery and the posterior knee capsule) block. The hypothesis is that postoperative pain control is comparable between the groups, with lower incidence of POUR in patients with no IM given.",[76,77,78,79],"Arthroplasties, Knee Replacement","Nerve Block","Urinary Retention Postoperative","Anesthesia, Spinal","2025-12-19",{"date":82,"type":83},"2025-12-29","ACTUAL",{"date":85,"type":83},"2025-06-24",{"date":87,"type":70},"2027-08-01",{"name":5,"class":6},1]