[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624080":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":31,"responsibleParty":47,"collaborators":12,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":12,"maxAge":12,"enrollmentInfo":60,"targetDuration":12,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":33,"whyStopped":12,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Beth Israel Deaconess Medical Center","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","NO_INTERVENTION","Patients randomized to the control group will receive a combined spinal intrathecal catheter and the same dosing of spinal medications. All aspects of care and monitoring will be the same as non-study patients. The control group will not receive a dose of intrathecal saline post-op",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Saline administered via the intrathecal catheter","EXPERIMENTAL","Patients randomized to the Intervention group will be administered 10ml of sterile normal saline via the intrathecal catheter post-op prior to catheter removal.",[18],"Drug: Normal Saline 10 mL Injection",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DRUG","Normal Saline 10 mL Injection","Patients randomized to this arm will have saline administration via intrathecal catheter post-op prior to removal",[14],[26],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Anna Fratello","CONTACT","617-632-8058","afratell@bidmc.harvard.edu",[32],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-71.05977,42.35843,{"lat":43,"lon":42},[46],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Joan Spiegel","Principal Investigator","100624080","phase-2-reversal-of-spinal-anesthesia-residual-motor-block-via-intrathecal-catheter-100624080",false,"NCT07404982","Reversal of Spinal Anesthesia Residual Motor Block Via Intrathecal Catheter","Reversal of Spinal Anesthesia Residual Motor Block Via Intrathecal Catheter: A Pilot Study","IT-Cath","Inclusion Criteria:\n\n1. Patients having elective lower extremity joint replacement surgery\n2. Patients \\>18 years\n\nExclusion Criteria:\n\n1. Contraindications to spinal anesthesia (refusal, lumbar spinal hardware, spinal abnormalities)\n2. Patient on anticoagulation not withheld\n3. Patient receiving re-operation on the same joint\n4. Prior intra-cranial bleeding\n5. Patient's ASA status \\>3\n6. Non-English speaking","ALL",{"count":61,"type":62},20,"ESTIMATED","INTERVENTIONAL",[65],"PHASE2","The purpose of this study is to determine the feasibility of administering a predetermined amount of normal saline into the intrathecal or subarachnoid space via a small spinal catheter to reduce or eliminate the effects of previously injected spinal anesthetic following lower extremity orthopedic surgery.",[68],"Joint Replacement Surgery",[70,71],"Joint Replacement","Knee Replacement","2026-04-16",{"date":74,"type":75},"2026-04-20","ACTUAL",{"date":77,"type":75},"2026-03-19",{"date":79,"type":62},"2027-12",{"name":5,"class":6},1]