[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05029726":3,"trial-entities:NCT05029726":175,"trial-summary:NCT05029726":186},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":29,"study_type":34,"primary_purpose":35,"phases":36,"enrollment_info":38,"interventions":41,"primary_outcomes":53,"secondary_outcomes":58,"sex":96,"minimum_age":97,"maximum_age":98,"healthy_volunteers":15,"eligibility_criteria":99,"std_ages":114,"locations":117,"central_contacts":140,"overall_officials":143,"references":145,"see_also_links":174},"NCT05029726","ORA20050502","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","RECRUITING","2027-04-30","2026-02","2026-02-17","2022-02-01","John O'Toole","OTHER",false,"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.","Opioid abuse and misuse remain a public health crisis in the United States, notably in patients with chronic pain from degenerative spine disease. Perioperative pain management for patients undergoing spinal surgery remains largely reliant on opioid medications, with several known adverse effects including, but not limited to delirium, postoperative urinary retention (POUR), constipation and nausea. These side effects contribute to increased hospital length of stay (LOS) with increased incidence of overall in-hospital complications, perioperative costs, and increased rates of opioid habituation and addiction.\n\nDependence on prescription opioids has been associated with wide-ranging social and economic consequences including increased opioid overdose resulting in death, growing opioid-related incarcerations, and spiraling opioid-related healthcare cost from treatment of addiction, opioid-related mental health issues, and debilitating chronic pain. Long-term requirements for opioid medications may be associated with the use of higher doses of opioids in the perioperative period for patients undergoing invasive surgery for spinal degenerative conditions. Studies have demonstrated that patients who consume fewer opioids for 30 days after surgery are less likely to progress to become chronic opioid users. Regional analgesic techniques have shown promise in decreasing post-operative pain and opioid requirements in thoracic and abdominal surgery but difficulties with post-operative neurological assessments have limited their use in spinal surgery. Inter-fascial plane blocks, however, have emerged as a safe and potentially useful regional analgesic technique to mitigate the pain-inducing effects of posterior spine surgery.\n\nErector Spinae Plane Blocks (ESPBs), specifically, involve ultra-sound guided injection of local anesthetic (LA) posteriorly beneath the erector spinae muscles resulting in longitudinal and ventrolateral spread of the anesthetic into the paravertebral space where the ventral and dorsal rami of the spinal nerves are located thereby inducing a multi-level analgesic effect. Depending upon the LA used, this effect may last for 4 to 36 hours.\n\nThe proposed study will examine the efficacy of preoperative ESPBs in reducing post-operative opioid utilization and its associated complications specifically after minimally invasive (MIS) lumbar spine surgery including both decompressive and instrumented fusion procedures. The guiding principle of MIS spine surgery is reduction of iatrogenic injury by utilizing muscle dilating approaches and tubular retractors rather than conventional open, subperiosteal muscle stripping techniques. The latter typically results in muscle denervation and devascularization as well as postoperative muscle atrophy and dead space creation that increase postoperative pain, muscle dysfunction, prolonged recovery times and complications. Since MIS spinal surgical procedures preserve normal paraspinal musculature compared to open surgery, the magnitude of effect of ESPBs may actually be more pronounced in this population.\n\nThe investigators hypothesize that by conducting this investigation within the rigor of a double-blinded, randomized placebo-controlled clinical trial, the results will definitively demonstrate that the addition of regional analgesia in the form of ESPB during MIS lumbar spine surgery will 1) reduce post-operative opioid consumption and 2) reduce opioid-related complications and hospital LOS but 3) have no adverse effects on postoperative pain control.",[19,20,21,22,23,24,25,26,27,28],"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",[30,31,32,33],"erector spinae plane block","minimally invasive spine surgery","regional anesthesia","randomized controlled trial","INTERVENTIONAL","TREATMENT",[37],"PHASE4",{"count":39,"type":40},125,"ESTIMATED",[42,48],{"type":43,"name":44,"description":45,"armGroupLabels":46},"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",[47],"Investigational",{"type":43,"name":49,"description":50,"armGroupLabels":51},"normal saline","normal saline in 30cc syringes administered using ESPB technique",[52],"Control",[54],{"measure":55,"description":56,"timeFrame":57},"Inpatient opioid consumption","Mean per day inpatient opioid consumption in morphine milligram equivalents (MME)","Every 1 day during inpatient admission up to 30 days",[59,63,67,71,75,79,81,84,88,90,92],{"measure":60,"description":61,"timeFrame":62},"Post-discharge opioid consumption","Total and per day mean postoperative opioid consumption after hospital discharge in MME as recorded in medication diary by patients","14 days (+\u002F- 7days) ,56 days (+\u002F- 14 days) and 90 days (+\u002F- 19) postoperatively",{"measure":64,"description":65,"timeFrame":66},"Postoperative opioid prescriptions filled","• Total MMEs of opioid prescriptions filled as found on the Illinois Prescription Monitoring Program website","From hospital discharge to 90 days postoperatively",{"measure":68,"description":69,"timeFrame":70},"Length of hospital stay","Duration of hospital stay postoperatively measured in days as determined by the time at which each patient met discharge criteria","From time of surgery to time discharge criteria met in hours, up to 2160 hours",{"measure":72,"description":73,"timeFrame":74},"Postoperative Urinary Retention (POUR)","Incidence of POUR measured as proportion of inpatient hospital days demonstrating the need for straight catheterization or foley placement","Immediately post-surgery to discharge, up to 90 days",{"measure":76,"description":77,"timeFrame":78},"Post-operative delirium","Incidence of post-operative delirium as measured by the need for placement of physical restraints","Immediately post-surgery to discharge",{"measure":76,"description":80,"timeFrame":74},"Incidence of post-operative delirium as measured by the administration of new anti-psychotic medications",{"measure":82,"description":83,"timeFrame":57},"Postoperative pain scores","Mean daily VAS (visual analog scale) pain scores recorded in the electronic medical record (EMR)",{"measure":85,"description":86,"timeFrame":87},"Patient-reported pain and functional outcomes","Change in Visual Analog Scale (VAS) for pain in the back and leg (0-10 with 10 being worst)","From baseline preoperative values to 6 week post-operative values",{"measure":85,"description":89,"timeFrame":87},"Change in Oswestry Disability Index (ODI; 0 to 100 with 100 being worst)",{"measure":85,"description":91,"timeFrame":87},"Change in Short Form 12\u002F6D (SF-12\u002F6D; 0 to 100 with 0 being worst)",{"measure":93,"description":94,"timeFrame":95},"Peri-operative complications","Prospectively documented medical and surgical complications\u002Fadverse events (AEs) including rates of readmission or reoperation for AEs","Time of surgery to 6 weeks postoperative","ALL","18 Years","80 Years",{"inclusion":100,"exclusion":104,"raw_text":113},[101,102,103],"Age 18-80","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","Willing and able to give consent",[105,106,107,108,109,110,111,112],"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)","Presence of an indwelling pain device (e.g., intrathecal opioid pump, spinal cord stimulator, dorsal root ganglion stimulator)","Known allergy to bupivacaine, clonidine or similar local anesthetics","Indication for surgery other than degenerative disease (e.g., neoplasm, infection, trauma)","Chronic kidney disease (stage 3 or greater), or hepatic failure","Active pregnancy","Disease process or mental illness that would preclude accurate evaluation of pain in the perioperative period","Active Worker's Compensation litigation","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",[115,116],"ADULT","OLDER_ADULT",[118],{"facility":119,"status":8,"city":120,"state":121,"zip":122,"country":123,"contacts":124,"geoPoint":137},"Rush University Medical Center","Chicago","Illinois","60612","United States",[125,130,134],{"name":126,"role":127,"phone":128,"email":129},"Bart Jacher","CONTACT","888-352-7874","bartosz_jacher@rush.edu",{"name":131,"role":127,"phone":132,"email":133},"Morgan Mulcahy","(888) 352-7874","morgan_l_mulcahy@rush.edu",{"name":135,"role":136},"John O'Toole, MD","PRINCIPAL_INVESTIGATOR",{"lat":138,"lon":139},41.85003,-87.65005,[141,142],{"name":126,"role":127,"phone":132,"email":129},{"name":131,"role":127,"phone":132,"email":133},[144],{"name":135,"affiliation":119,"role":136},[146,150,153,156,159,162,165,168,171],{"pmid":147,"type":148,"citation":149},"30180150","BACKGROUND","Chin KJ, Lewis S. Opioid-free Analgesia for Posterior Spinal Fusion Surgery Using Erector Spinae Plane (ESP) Blocks in a Multimodal Anesthetic Regimen. Spine (Phila Pa 1976). 2019 Mar 15;44(6):E379-E383. doi: 10.1097\u002FBRS.0000000000002855.",{"pmid":151,"type":148,"citation":152},"31482311","Chin KJ, Dinsmore MJ, Lewis S, Chan V. Opioid-sparing multimodal analgesia with bilateral bi-level erector spinae plane blocks in scoliosis surgery: a case report of two patients. Eur Spine J. 2020 Dec;29(Suppl 2):138-144. doi: 10.1007\u002Fs00586-019-06133-8. Epub 2019 Sep 3.",{"pmid":154,"type":148,"citation":155},"27501016","Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097\u002FAAP.0000000000000451.",{"pmid":157,"type":148,"citation":158},"29704223","Melvin JP, Schrot RJ, Chu GM, Chin KJ. Low thoracic erector spinae plane block for perioperative analgesia in lumbosacral spine surgery: a case series. Can J Anaesth. 2018 Sep;65(9):1057-1065. doi: 10.1007\u002Fs12630-018-1145-8. Epub 2018 Apr 27.",{"pmid":160,"type":148,"citation":161},"31033625","Singh S, Choudhary NK, Lalin D, Verma VK. Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Oct;32(4):330-334. doi: 10.1097\u002FANA.0000000000000603.",{"pmid":163,"type":148,"citation":164},"30424594","Ueshima H, Inagaki M, Toyone T, Otake H. Efficacy of the Erector Spinae Plane Block for Lumbar Spinal Surgery: A Retrospective Study. Asian Spine J. 2019 Apr;13(2):254-257. doi: 10.31616\u002Fasj.2018.0114. Epub 2018 Nov 15.",{"pmid":166,"type":148,"citation":167},"33828209","van den Broek RJC, van de Geer R, Schepel NC, Liu WY, Bouwman RA, Versyck B. Evaluation of adding the Erector spinae plane block to standard anesthetic care in patients undergoing posterior lumbar interbody fusion surgery. Sci Rep. 2021 Apr 7;11(1):7631. doi: 10.1038\u002Fs41598-021-87374-w.",{"pmid":169,"type":148,"citation":170},"25417827","Armaghani SJ, Lee DS, Bible JE, Archer KR, Shau DN, Kay H, Zhang C, McGirt MJ, Devin CJ. Preoperative opioid use and its association with perioperative opioid demand and postoperative opioid independence in patients undergoing spine surgery. Spine (Phila Pa 1976). 2014 Dec 1;39(25):E1524-30. doi: 10.1097\u002FBRS.0000000000000622.",{"pmid":172,"type":148,"citation":173},"30045343","Kalakoti P, Hendrickson NR, Bedard NA, Pugely AJ. Opioid Utilization Following Lumbar Arthrodesis: Trends and Factors Associated With Long-term Use. Spine (Phila Pa 1976). 2018 Sep 1;43(17):1208-1216. doi: 10.1097\u002FBRS.0000000000002734.",[],{"nct_id":4,"conditions":176,"biomarkers":185},[28,177,178,179,19,180,181,182,183,184],"Degenerative spondylolisthesis","Intervertebral Disc Degenerative Disorder","Lumbar radiculopathy","Lumbar spine instability","Lumbar spondylolisthesis","Lumbar spondylosis","Prolapsed lumbar intervertebral disc","Synovial cyst",[],{"nct_id":4,"found":187,"summary":188,"prompt_version":197},true,{"design":189,"status":190,"heading":6,"summary":191,"follow_up":192,"word_count":193,"commitments":194,"compensation":195,"drugs_mentioned":196},"This is an interventional study with a planned enrollment of 125 participants. It compares two different drug interventions.","completed","This study is looking at ways to reduce the need for opioid pain medications after minimally invasive lumbar (lower back) spine surgery. Researchers are comparing two different injections given during surgery: one containing Bupivacaine-Epinephrine 0.25%-1:200,000 plus clonidine, and another containing normal saline (salt water). Both injections are given using a technique called ESPB. The goal is to see if the Bupivacaine-Epinephrine injection can help patients use less opioid pain medication after surgery. You may be able to join if you are between 18 and 80 years old and are having certain types of minimally invasive lumbar spine surgery for conditions like lumbar spinal stenosis or disc herniation. The study is currently unclear on its recruitment status.","Your opioid consumption will be measured every day during your inpatient admission, for up to 30 days.",116,"Not specified in the trial record.","Not stated in the trial record.",[49],"v2"]