[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624080":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":32,"overallOfficials":13,"centralContacts":38,"locations":44,"responsibleParty":60,"collaborators":13,"id":64,"slug":13,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":13,"maxAge":13,"enrollmentInfo":72,"targetDuration":13,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":46,"whyStopped":13,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Beth Israel Deaconess Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Time to residual motor blockade reversal","Time to residual motor blockade reversal as measured by Bromage score following saline administration and catheter removal, up to a maximum of 60 minutes.","Initiation of spinal anesthetic to reversal, up to sixty minutes after removal of catheter.",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","This is a prospective, randomized, interventional study to assess the feasibility and effectiveness of administering normal saline into the intrathecal or subarachnoid space through a small gauge epidural catheter via a single spinal needle to reverse residual anesthesia following lower extremity orthopedic surgery. This method is adapted from observations in obstetric populations where saline administered via the spinal catheter reduced headaches. This study investigates whether orthopedic patients will also receive unique benefits.\n\nResearch procedures overview:\n\n* Randomization to intervention or control arm,\n* Use of 6-inch BD 20-gauge Quincke spinal needle, through which a B. Braun Perifix 24-gauge polyurethane catheter\n* Administration of normal saline\n* Administration of post-operative survey while in the PACU 1 hour\n* Follow-up survey 3 days post-surgery\n* Medical record review and abstraction.",[22,26],{"label":23,"type":24,"description":25,"interventionNames":13},"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",{"label":27,"type":28,"description":29,"interventionNames":30},"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.",[31],"Drug: Normal Saline 10 mL Injection",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":13},"DRUG","Normal Saline 10 mL Injection","Patients randomized to this arm will have saline administration via intrathecal catheter post-op prior to removal",[27],[39],{"name":40,"role":41,"phone":42,"phoneExt":13,"email":43},"Anna Fratello","CONTACT","617-632-8058","afratell@bidmc.harvard.edu",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-71.05977,42.35843,{"lat":56,"lon":55},[59],{"name":40,"role":41,"phone":42,"phoneExt":13,"email":43},{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Joan Spiegel","Principal Investigator","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":73,"type":74},20,"ESTIMATED","INTERVENTIONAL",[77],"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.",[80],"Joint Replacement Surgery",[82,83],"Joint Replacement","Knee Replacement","2026-04-16",{"date":86,"type":87},"2026-04-20","ACTUAL",{"date":89,"type":87},"2026-03-19",{"date":91,"type":74},"2027-12",{"name":5,"class":6},1]