[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100441542":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":63,"collaborators":26,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":26,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":95,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Rush University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Investigational","EXPERIMENTAL","Patients will undergo regional ESPB with bupivacaine plus clonidine in the holding area of the OR immediately prior to surgery. 30mL of 0.25% bupivacaine\u002F1:200,000 epinephrine\u002F50mcg clonidine will be administered bilaterally (total 60ml) to the lumbar paraspinal erector spine plane using ultrasound-guidance.",[13],"Drug: Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","PLACEBO_COMPARATOR","Patients will receive a placebo injection of normal saline via the same ESPB technique. 30ml of normal saline will be administered bilaterally (total 60ml) to the lumbar paraspinal erector spine plane using ultrasound-guidance.",[19],"Drug: normal saline",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine","Bupivacaine-Epinephrine 0.25%-1:200,000 plus clonidine 50 micrograms in 30cc syringes administered as ESPB",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"normal saline","normal saline in 30cc syringes administered using ESPB technique",[15],[32],{"name":33,"affiliation":5,"role":34},"John O'Toole, MD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Bart Jacher","CONTACT","(888) 352-7874","bartosz_jacher@rush.edu",{"name":42,"role":38,"phone":39,"phoneExt":26,"email":43},"Morgan Mulcahy","morgan_l_mulcahy@rush.edu",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Chicago","Illinois","60612","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-87.65005,41.85003,{"lat":56,"lon":55},[59,61,62],{"name":37,"role":38,"phone":60,"phoneExt":26,"email":40},"888-352-7874",{"name":42,"role":38,"phone":39,"phoneExt":26,"email":43},{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","John O'Toole","Professor of Neurosurgery","100441542","phase-4-regional-anesthesia-in-minimally-invasive-lumbar-spine-surgery-100441542",false,"NCT05029726","Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery","Randomized, Placebo-controlled Trial of Erector Spinae Plane Blocks (ESPB) for Perioperative Pain Management for Minimally Invasive (MIS) Lumbar Spine Surgery","Inclusion Criteria:\n\n* Age 18-80\n* Undergoing one of 3 procedure types: 1) 2 or more levels of MIS decompression (e.g., discectomy, foraminotomy, laminectomy); 2) 1-3 levels of MIS transforaminal lumbar interbody fusion (TLIF) (with or without additional levels of MIS decompression for no greater than 3 total operative levels); 3) 1-3 levels of anterior lumbar interbody fusion (ALIF) or MIS lateral lumbar interbody fusion (LLIF) accompanied by posterior percutaneous instrumentation at the same levels\n* Willing and able to give consent\n\nExclusion Criteria:\n\n* Opioid tolerant at the time of the surgical procedure--defined as consuming greater than 30mg of morphine milligram equivalents (MME) daily (https:\u002F\u002Fwww.cdc.gov\u002Fdrugoverdose\u002Fprescribing\u002Fguideline.html)\n* Presence of an indwelling pain device (e.g., intrathecal opioid pump, spinal cord stimulator, dorsal root ganglion stimulator)\n* Known allergy to bupivacaine, clonidine or similar local anesthetics\n* Indication for surgery other than degenerative disease (e.g., neoplasm, infection, trauma)\n* Chronic kidney disease (stage 3 or greater), or hepatic failure\n* Active pregnancy\n* Disease process or mental illness that would preclude accurate evaluation of pain in the perioperative period\n* Active Worker's Compensation litigation","ALL","18 Years","80 Years",{"count":78,"type":79},125,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","Opioid overuse is a widespread public health crisis in the United States with increasing rates of addiction and overdose deaths from prescription opioids. Reducing the need for opiate analgesics in the post-operative setting has become a high priority in minimizing long-term opioid use in surgical patients. This study will serve to demonstrate the efficacy of the addition of regional analgesic techniques in reducing post-operative opioid requirements in patients undergoing common lumbar spinal surgical procedures.",[85,86,87,88,89,90,91,92,93,94],"Lumbar Spinal Stenosis","Lumbar Disc Herniation","Lumbar Spondylolisthesis","Lumbar Spondylosis","Lumbar Radiculopathy","Lumbar Spine Instability","Synovial Cyst","Degenerative Disc Disease","Degenerative Spondylolisthesis","Degenerative Intervertebral Discs",[96,97,98,99],"erector spinae plane block","minimally invasive spine surgery","regional anesthesia","randomized controlled trial","2026-02-11",{"date":102,"type":103},"2026-02-17","ACTUAL",{"date":105,"type":103},"2022-02-01",{"date":107,"type":79},"2027-04-30",{"name":65,"class":6},1]