[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656955":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":29,"studyPopulation":18,"armGroups":30,"interventions":44,"overallOfficials":18,"centralContacts":67,"locations":73,"responsibleParty":87,"collaborators":18,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":18,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":18,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":112,"overallStatus":115,"whyStopped":18,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Aydin Adnan Menderes University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"To evaluate the effect of ESP block on the BPI score at 3 months postoperatively in patients undergoing lumbar spine surgery.","Chronic postoperative pain severity and its impact on daily functioning will be assessed at 3 months after surgery using the Brief Pain Inventory (BPI). BPI scores will be compared between the ESP block group and the control group to evaluate the effect of ESP block on chronic postoperative pain.","3 months after surgery",[14],{"measure":15,"description":16,"timeFrame":17},"Postoperative NRS Score and Neuropathic Pain Assessed by S-LANSS","Postoperative acute pain intensity will be assessed using the Numeric Rating Scale (NRS) at 30 minutes and at 1, 6, 12, and 24 hours after surgery. The NRS score obtained at 12 hours postoperatively will serve as the primary time point for the between-group comparison of acute postoperative pain. Neuropathic pain will be evaluated at 3 months after surgery using the Self-administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS). To determine the effect of the ESP block on acute postoperative pain and neuropathic pain, the resulting scores will be compared between the ESP block group and the control group.","12.hours after surgery for NRS; 3 months after surgery for S-LANSS",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":23,"observationalModel":18,"timePerspective":18,"maskingInfo":24},"RANDOMIZED","PARALLEL","The study was designed as a double blind,prospective randomized controlled trial","PREVENTION",{"masking":25,"maskingDescription":18,"whoMasked":26},"DOUBLE",[27,28],"PARTICIPANT","CARE_PROVIDER","Acute postoperative pain is common following spinal surgery, and in some patients, pain may persist beyond the expected recovery period and develop into chronic postoperative pain. Inadequate perioperative pain control may contribute to the development of persistent postoperative pain. Therefore, it is important to evaluate the effects of regional anesthesia techniques used as part of multimodal analgesia not only on early postoperative pain but also on long-term pain outcomes.\n\nThe erector spinae plane (ESP) block is an ultrasound-guided regional anesthesia technique that can be used to provide perioperative analgesia in patients undergoing spinal surgery. This study will investigate the effect of ESP block on acute postoperative pain and, particularly, on the development and severity of chronic postoperative pain following spinal surgery.\n\nPostoperative pain intensity will be assessed during the early postoperative period, and participants will subsequently be followed for long-term pain outcomes. Chronic pain severity, its impact on daily activities, and neuropathic pain characteristics will be evaluated using standardized and validated assessment tools.\n\nData will be compared between patients who receive ESP block and those who do not receive the block to determine the potential effect of ESP block on long-term pain outcomes following spinal surgery.",[31,40],{"label":32,"type":33,"description":18,"interventionNames":34},"ESP Block Group","ACTIVE_COMPARATOR",[35,36,37,38,39],"Diagnostic Test: NRS SCORE","Diagnostic Test: Total tramadol consumption","Drug: Post Operative Pain Relievers","Diagnostic Test: S-LANSS","Diagnostic Test: BPI",{"label":41,"type":42,"description":18,"interventionNames":43},"Control Group","EXPERIMENTAL",[35,36,37,38,39],[45,50,54,59,63],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":18},"DIAGNOSTIC_TEST","NRS SCORE","An 11-point Numerical Rating Scale (NRS), where 0 indicated no pain and 10 represented the worst pain imaginable, was used to assess patients' pain levels.",[41,32],{"type":46,"name":51,"description":52,"armGroupLabels":53,"otherNames":18},"Total tramadol consumption","The total number of patient-controlled analgesia (PCA) bolus doses delivered within the first 24 hours will record",[41,32],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":18},"DRUG","Post Operative Pain Relievers","Operasyon bitiminde hastalar, postoperatif derlenme odasına alındıkları andan itibaren ilk saat 30. dk.,1.,6.,12.24.saatlerde ağrı düzeyleri Numeric Rating Scale (NRS) sistemi ile belirlenerek kayıt altına alınacaktır. Hastaya serviste tramadol PCA ve sekiz saatte bir parasetamol uygulanmaktadır. Hastanın servis takiplerinde ise saatlik NRS takibine devam edilmesi planlanmıştır. Bu dönemde NRS 4 ve üzerinde olması durumunda intramuskuler 75 mg diklofenak sodyum uygulanacaktır. Analjezi tüketim miktarı, kurtarma analjeziği ihtiyaçları ve saatleri ayrıntılı olarak not edilecek, ve belirlenen saatlerdeki NRS skorları yanı sıra kurtarma analjeziği kullanımı da istatistiksel değerlendirmeye tutulacaktır. Postoperatif analjezi planı tüm hastalara aynı şekilde uygulanacaktır.",[41,32],{"type":46,"name":60,"description":61,"armGroupLabels":62,"otherNames":18},"S-LANSS","The Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS), a 7-item scale with scores ranging from 0 to 24, was used to assess neuropathic pain characteristics",[41,32],{"type":46,"name":64,"description":65,"armGroupLabels":66,"otherNames":18},"BPI","The BPI was used to assess pain severity and pain interference in daily life. Pain severity was calculated as the mean of 4 items, while pain interference was calculated as the mean of 7 daily life domains, with scores ranging from 0 to 10. Higher scores indicated greater pain severity and interference.",[41,32],[68],{"name":69,"role":70,"phone":71,"phoneExt":18,"email":72},"SİNEM SARI, PROF DR","CONTACT","902564441256","sarisinem@yahoo.com",[74],{"facility":75,"status":18,"city":76,"state":18,"zip":77,"country":78,"countryCode":18,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"AYDIN ADNAN MENDERES ÜNİVERSİTESİ TIP FAKÜLTESİ HASTANESİ, Aydın, 09100","Aydin","09100","Turkey (Türkiye)",{"type":80,"coordinates":81},"Point",[82,83],27.83963,37.84501,{"lat":83,"lon":82},[86],{"name":69,"role":70,"phone":71,"phoneExt":18,"email":72},{"type":88,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","SINEM SARI","PROF DR","100656955","erector-spinae-plane-block-for-chronic-pain-after-spinal-surgery-100656955",false,"NCT07834502","Erector Spinae Plane Block for Chronic Pain After Spinal Surgery","Evaluation of the Effect of the Erector Spinae Plane (ESP) Block on Chronic Postoperative Pain After Lumbar Spine Surgery","Inclusion Criteria:\n\n1. Undergoing elective lumbar spinal surgery\n2. ASA I-III\n3. Aged 18-75 years\n\nExclusion Criteria:\n\nRefusal to participate at the time of enrollment Request to withdraw from the study Inability to provide informed consent Emergency surgery Bleeding diathesis Presence of contraindications to the local anesthetic agents used in the study Chronic opioid use Psychiatric disorders Infection at the injection site","ALL","18 Years","75 Years",{"count":102,"type":103},80,"ESTIMATED","INTERVENTIONAL",[106],"NA","The aim of this study is to evaluate whether the erector spinae plane (ESP) block reduces acute and chronic postoperative pain in patients undergoing spinal surgery.\n\nParticipants will be assigned to study groups according to the study protocol. Postoperative pain will be evaluated using standardized pain assessment tools. Acute postoperative pain will be assessed using the Numeric Rating Scale (NRS), while chronic pain and its impact on daily life will be evaluated using the Brief Pain Inventory (BPI). Neuropathic pain symptoms will also be assessed using the Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS).\n\nThe study aims to determine whether the use of ESP block as part of perioperative pain management can improve postoperative pain outcomes following spinal surgery.",[109,110,111],"Postoperative Pain","Chronic Postsurgical Pain","Spinal Surgery",[113,114,110],"Erector Spinae Plane Block","Brief Pain Inventory","NOT_YET_RECRUITING","2026-09-16",{"date":118,"type":119},"2026-09-22","ACTUAL",{"date":121,"type":103},"2026-10-01",{"date":123,"type":103},"2029-01-01",{"name":5,"class":6},1]