[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630540":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":66,"centralContacts":77,"locations":87,"responsibleParty":112,"collaborators":10,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":10,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":10,"studyType":128,"phases":10,"briefSummary":129,"conditions":130,"keywords":135,"overallStatus":90,"whyStopped":10,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Marmara University","OTHER",[8,16,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1- Opioid-Based Anesthesia Group",null,"Patients receiving intraoperative opioid-based analgesia without ESP or other truncal regional anesthesia techniques.",[13,14,15],"Drug: Opioid based Anesthesia","Device: Intraoperative ANI Monitoring","Device: Bispectral Index Monitoring",{"label":17,"type":10,"description":18,"interventionNames":19},"Group 2- Opioid-Free Anesthesia Group","Patients receiving opioid-free multimodal anesthesia, with or without ESP block, and non-opioid agents such as acetaminophen, lidocaine, ketamine, dexmedetomidine, magnesium sulfate, and esmolol.",[20,21,14,15],"Drug: Opioid-free Anesthesia","Procedure: Erector Spinae Plane Block",{"label":23,"type":10,"description":24,"interventionNames":25},"Group 3- ESP Block + Opioid Group","Patients receiving ultrasound-guided erector spinae plane (ESP) block plus intraoperative opioid analgesia such as remifentanil or morphine.",[21,13,14,15],[27,34,44,51,59],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Opioid-free Anesthesia","A multimodal opioid-free anesthetic regimen including ESP block and agents such as acetaminophen, lidocaine, dexmedetomidine, ketamine, magnesium sulfate, and esmolol. No intraoperative opioids are given.\n\nApplies to Groups:Group 1 (Opioid-Free Anesthesia Group)",[17],[33],"OFA",{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"PROCEDURE","Erector Spinae Plane Block","Before surgery, after endotracheal intubation of the patient in the prone position, a bilateral ultrasound-guided erector spinae plane block was performed at the vertebral level above the surgical site, using 20 mL of 0.25% bupivacaine per side in the lumbar region.\"\n\nApplies to Groups:\n\n* Group 2 (for patients who receive ESP)\n* Group 3 (ESP + Opioid Group)",[17,23],[40,41,42,43],"ESP","ESPB","L-ESPB","L-ESP",{"type":28,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Opioid based Anesthesia","Intraoperative opioid analgesia (e.g., remifentanil infusion and\u002For morphine) administered according to standard clinical practice.\n\nApplies to Groups:\n\n* Group 3 (ESP + Opioid Group)\n* Group 1 (Opioid-Based Anesthesia Group)",[9,23],[49,50],"OBA","Conventional opioid anesthesia",{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"DEVICE","Intraoperative ANI Monitoring","The Analgesia Nociception Index (ANI) device is used intraoperatively to continuously assess autonomic nervous system responses to nociceptive stimuli. ANI values are recorded in all participants and compared across anesthetic cohorts for evaluation of intraoperative analgesic adequacy.",[9,17,23],[57,58],"ANI","ANI monitoring",{"type":52,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"Bispectral Index Monitoring","Continuous intraoperative depth of anesthesia monitoring using the Bispectral Index (BIS) device. BIS values are recorded throughout the procedure to assist in titration of anesthetic agents and to standardize anesthesia depth across study cohorts. The BIS device is used for monitoring only, and no device-related investigational procedures are performed.",[9,17,23],[64,65],"BIS","BIS Monitoring",[67,71,74],{"name":68,"affiliation":69,"role":70},"burcu Akyüz irfanoğlu, MD","marmara university hospital","PRINCIPAL_INVESTIGATOR",{"name":72,"affiliation":69,"role":73},"seniyye ülgen zengin, MD","STUDY_CHAIR",{"name":75,"affiliation":69,"role":76},"meliha orhon ergün, MD","STUDY_DIRECTOR",[78,83],{"name":79,"role":80,"phone":81,"phoneExt":10,"email":82},"Burcu Akyüz Irfanoğlu, MD","CONTACT","900-555-725-9649","brcakyz1@gmail.com",{"name":84,"role":80,"phone":85,"phoneExt":10,"email":86},"Seniyye Ulgen zengin, MD","900-505-714-2443","ulgen_t@yahoo.com",[88],{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":94,"countryCode":10,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Marmara university hospital","RECRUITING","Istanbul","Maltepe","34722","Turkey (Türkiye)",{"type":96,"coordinates":97},"Point",[98,99],28.94966,41.01384,{"lat":99,"lon":98},[102,104,106,109,110],{"name":103,"role":80,"phone":85,"phoneExt":10,"email":82},"BURCU Akyüz İrfanoğlu, MD",{"name":84,"role":80,"phone":105,"phoneExt":10,"email":86},"900-505-714-24-43",{"name":107,"role":108,"phone":10,"phoneExt":10,"email":10},"Meliha Orhon Ergün, MD","SUB_INVESTIGATOR",{"name":79,"role":108,"phone":10,"phoneExt":10,"email":10},{"name":111,"role":70,"phone":10,"phoneExt":10,"email":10},"Seniyye Ulgen Zengin, MD",{"type":70,"investigatorFullName":113,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Ulgen Zengin","Associate Professor of Anesthesiology, Principal Investigator","100630540","opioid-free-and-opioid-based-anesthesia-in-elective-lumbar-spine-surgery-100630540",false,"NCT07489001","Opioid Free and Opioid Based Anesthesia in Elective Lumbar Spine Surgery","Prospective Comparative Evaluation of Intra-operative and Postoperative Outcomes Associated With Opioid Free Versus Opioid Based Anesthesia Techniques in Patients Undergoing Elective Lumbar Spinal Surgery","Inclusion Criteria:\n\n* Adults aged 18 to 75 years\n* Elective surgery only\n* Scheduled for elective lumbar spinal surgery (lumbar spinal stenosis and\u002For lumbar disc herniation)\n* ASA physical status I-III\n* No previous lumbar spine surgery\n* Able to provide written informed consent\n* BIS monitoring available and recorded\n* Ability to comply with postoperative pain assessment (NRS\u002FVAS)\n* Stable hemodynamic status preoperatively\n\nExclusion Criteria:\n\n* Age younger than 18 or older than 75\n* Inability or unwillingness to provide informed consent\n* Severe psychiatric disease or cognitive impairment\n* Emergency surgery cases\n* BMI \\> 40 kg\u002Fm²\n* Pregnancy\n* Uncontrolled hypertension, arrhythmia, or severe cardiac disease\n* Renal failure\n* Chronic beta-blocker use\n* Coagulation disorders\n* Chronic alcohol dependence or substance use\n* Neurological deficits affecting perception of pain\n* Chronic pain syndrome (fibromyalgia, chronic LBP \\> 3 months)\n* Chronic gabapentinoid use\n* Anemia\n* Known allergy to any anesthetic or analgesic agents used in the study\n* Local infection at the intended ESP block injection site\n* Intraoperative change in anesthetic technique that deviates from initial planned management\n* Pediatric patients (\\\u003C18 years)","ALL","18 Years","75 Years",{"count":126,"type":127},75,"ESTIMATED","OBSERVATIONAL","This prospective, observational, non-randomized clinical study aims to evaluate the intraoperative and postoperative effects of opioid-free multimodal anesthesia compared with opioid-containing anesthesia methods in adult patients undergoing lumbar spinal surgery. Patients will be managed according to routine clinical practice and assigned to one of three groups based on the analgesic strategy used by the attending anesthesiologist: (1) opioid-free anesthesia using multimodal agents and\u002For erector spinae plane (ESP) block; (2) ESP block plus intraoperative opioids; or (3) opioid-based anesthesia without regional blocks.\n\nThe primary objective is to compare postoperative pain control and opioid requirements within the first 48 hours after surgery. Secondary objectives include evaluating opioid-related side effects such as nausea, vomiting, pruritus, constipation, delayed mobilization, urinary retention, and postoperative complications classified according to the Clavien-Dindo system. Standard postoperative analgesia, including intravenous morphine patient-controlled analgesia (PCA), acetaminophen, and NSAIDs, will be provided for all patients.\n\nThe study aims to determine whether an opioid-free multimodal analgesic approach can reduce opioid consumption and related adverse effects while maintaining adequate analgesia in patients undergoing lumbar spinal surgery.",[131,132,133,134],"Lumbar Spinal Stenosis","Lumbar Disc Herniation With Radiculopathy","Lumbar Degenerative Spondylolisthesis","Lumbar Disc Degeneration",[136,137,36,138,139,140,141,142,143],"Opioid-Free Anesthesia","Multimodal Analgesia","ESP Block","Postoperative Pain","Opioid-Related Adverse Effects","Opioid Consumption","Lumbar Spine Surgery","Regional Anesthesia","2026-03-18",{"date":146,"type":147},"2026-03-23","ACTUAL",{"date":149,"type":147},"2025-12-09",{"date":151,"type":127},"2026-12-10",{"name":5,"class":6},1]