[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658466":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":36,"studyPopulation":37,"armGroups":38,"interventions":48,"overallOfficials":54,"centralContacts":59,"locations":69,"responsibleParty":88,"collaborators":32,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":32,"eligibilityCriteria":96,"healthyVolunteers":93,"sex":97,"minAge":98,"maxAge":32,"enrollmentInfo":99,"targetDuration":102,"studyType":103,"phases":32,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":71,"whyStopped":32,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Taksim Egitim ve Arastirma Hastanesi","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Spinal Anaesthesia Success on the First Needle Insertion","Percentage of patients in whom spinal anaesthesia is successfully performed on the first needle insertion, compared between patients with and without previous lumbar spine surgery.","During the spinal anaesthesia procedure, on the day of surgery.",[14,18,21,25,29],{"measure":15,"description":16,"timeFrame":17},"Total Number of Skin Punctures","Total number of separate skin punctures made during the spinal anaesthesia procedure, compared between patients with and without previous lumbar spine surgery. Each needle insertion through the skin counts as a new puncture.","From the first needle insertion until completion or abandonment of the spinal anaesthesia procedure, on the day of surgery.",{"measure":19,"description":20,"timeFrame":12},"Spinal Anaesthesia Procedure Duration","Time in seconds after back covered to completion of intrathecal injection. For unsuccessful procedures, time until abandonment will be recorded separately.",{"measure":22,"description":23,"timeFrame":24},"Time to Maximum Sensory Block Level","Time in minutes from completion of intrathecal injection to the first observation of the maximum sensory block level.","Following intrathecal injection, on the day of surgery.",{"measure":26,"description":27,"timeFrame":28},"Blood Pressure Changes","Changes in systolic and diastolic blood pressure, measured in mmHg, from the pre-spinal baseline during the first 30 minutes after spinal anaesthesia","Before spinal anaesthesia and during the first 30 minutes after intrathecal injection.",{"measure":30,"description":31,"timeFrame":28},"Heart Rate Changes","Changes in heart rate, measured in beats per minute, from the pre-spinal baseline during the first 30 minutes after spinal anaesthesia.",null,{"allocation":32,"interventionModel":32,"interventionModelDescription":32,"primaryPurpose":32,"observationalModel":34,"timePerspective":35,"maskingInfo":32},"COHORT","PROSPECTIVE","Previous lumbar spine surgery can alter anatomical landmarks and produce scar tissue that may make spinal anaesthesia technically more difficult. This study will examine the association between prior lumbar surgery and technical performance during routine spinal anaesthesia.\n\nPatients will be grouped according to whether they have a history of lumbar spine surgery. Anaesthesia decisions will be made by treating clinicians who are not involved in research data collection. No anaesthetic technique or treatment will be assigned by the researchers.\n\nDemographic and clinical characteristics, previous lumbar surgery details, and procedural observations will be collected prospectively using a standardized form. This will allow technical difficulties to be examined alongside block characteristics and early hemodynamic changes.\n\nAn internal pilot phase will include 25 patients in each group. Pilot estimates of first-insertion success will inform the sample size calculation for the main study. Group-specific success rates and their absolute difference will be reported with 95% confidence intervals.","Adults aged 18 years or older with ASA physical status I-III who are scheduled to receive spinal anaesthesia as part of routine surgical care at Taksim Training and Research Hospital, Istanbul, Turkey. The study population will include patients with previous lumbar spine surgery and a comparison cohort without previous lumbar spine surgery.",[39,44],{"label":40,"type":32,"description":41,"interventionNames":42},"Prior Lumbar Surgery Group","Adults with a history of lumbar spine surgery who are scheduled to receive spinal anaesthesia as part of routine care for another surgical procedure.",[43],"Procedure: spinal anesthesia",{"label":45,"type":32,"description":46,"interventionNames":47},"Control Group Without Prior Lumbar Surgery","Adults without a history of lumbar spine surgery who are scheduled to receive spinal anaesthesia as part of routine surgical care. This cohort will serve as the comparison group.",[43],[49],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":32},"PROCEDURE","spinal anesthesia","Single-shot spinal anaesthesia administered as part of routine surgical care in patients with or without previous lumbar spine surgery. The treating anaesthesiologist will determine the puncture site, needle type, approach, and anaesthetic drug and dose according to clinical judgment. Researchers will not assign or modify the procedure and will only collect observational data.",[45,40],[55],{"name":56,"affiliation":57,"role":58},"Celal Kaya","Taksim Training and Research Hospital","PRINCIPAL_INVESTIGATOR",[60,65],{"name":61,"role":62,"phone":63,"phoneExt":32,"email":64},"Celal Kaya, MD","CONTACT","905435176760","c.kaya47@hotmail.com",{"name":66,"role":62,"phone":67,"phoneExt":32,"email":68},"Sena Yildiz, MD","905372630427","dr.senayildiz@hotmail.com",[70],{"facility":57,"status":71,"city":72,"state":32,"zip":32,"country":73,"countryCode":32,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"RECRUITING","Istanbul","Turkey (Türkiye)",{"type":75,"coordinates":76},"Point",[77,78],28.94966,41.01384,{"lat":78,"lon":77},[81,83,84,86],{"name":82,"role":62,"phone":63,"phoneExt":32,"email":64},"celal kaya",{"name":66,"role":62,"phone":67,"phoneExt":32,"email":68},{"name":85,"role":58,"phone":32,"phoneExt":32,"email":32},"celal kaya, MD",{"name":66,"role":87,"phone":32,"phoneExt":32,"email":32},"SUB_INVESTIGATOR",{"type":89,"investigatorFullName":56,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"SPONSOR_INVESTIGATOR","Consultant in Anaesthesiology and Intensive Care","100658466","spinal-anaesthesia-success-in-patients-with-previous-lumbar-spine-surgery-100658466",false,"NCT07852767","Spinal Anaesthesia Success in Patients With Previous Lumbar Spine Surgery","Inclusion Criteria:\n\n* Age 18 years or older.\n* American Society of Anaesthesiologists (ASA) physical status classification I-III.\n* Scheduled to receive clinically indicated spinal anaesthesia for surgery, performed by clinicians other than the researchers collecting study data.\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Any clinical contraindication to spinal anaesthesia.\n* Refusal to participate or inability to provide written informed consent.\n* Severe cognitive impairment preventing study assessments.\n* Planned epidural or combined spinal-epidural anaesthesia.\n* Inability to reliably record study data.","ALL","18 Years",{"count":100,"type":101},50,"ESTIMATED","1 Day","OBSERVATIONAL","The goal of this observational study is to compare spinal anaesthesia success in adults with and without previous lower back surgery. The main question it aims to answer is:\n\n\\- Does previous lower back surgery affect the success of spinal anaesthesia on the first needle insertion?\n\nParticipants will receive spinal anaesthesia as part of their usual medical care. Researchers will record needle attempts, procedure time, and anaesthesia effectiveness. Participation will not involve additional procedures or changes to routine care.",[106,107],"Spinal Surgery","Spinal Aneshtesia",[109,110,111],"Previous lumbar spine surgery","Neuraxial anesthesia","Spinal anesthesia","2026-10-01",{"date":114,"type":115},"2026-10-06","ACTUAL",{"date":112,"type":115},{"date":118,"type":101},"2026-12-31",{"name":56,"class":6},1]