[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624080":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":31,"responsibleParty":48,"collaborators":12,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":12,"maxAge":12,"enrollmentInfo":61,"targetDuration":12,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":33,"whyStopped":12,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"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":47,"phoneExt":12,"email":30},"6176328058",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"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\n7. Bromage score of 6 at the time of first PACU assessment post-enrollment","ALL",{"count":62,"type":63},24,"ESTIMATED","INTERVENTIONAL",[66],"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.",[69],"Joint Replacement Surgery",[71,72],"Joint Replacement","Knee Replacement","2026-07-30",{"date":75,"type":76},"2026-07-31","ACTUAL",{"date":78,"type":76},"2026-03-19",{"date":80,"type":63},"2027-12",{"name":5,"class":6},1]