[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657975":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":28,"studyPopulation":29,"armGroups":30,"interventions":37,"overallOfficials":48,"centralContacts":61,"locations":67,"responsibleParty":84,"collaborators":24,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":24,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":24,"maxAge":95,"enrollmentInfo":96,"targetDuration":24,"studyType":99,"phases":24,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":110,"whyStopped":24,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Istanbul University - Cerrahpasa","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Ultrasonographic Skin-to-Epidural Distance","Distance between the skin and the epidural space measured by ultrasonography at the intervertebral levels between the twelfth thoracic vertebra and the first lumbar vertebra, between the first and second lumbar vertebrae, between the second and third lumbar vertebrae, and between the third and fourth lumbar vertebrae in infants.","During perioperative ultrasonographic assessment immediately after induction of general anesthesia",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Comparison of Parasagittal Oblique and Transverse Median Ultrasound Measurements","Comparison of skin-to-epidural distance measurements obtained in the paramedian sagittal oblique and transverse median ultrasound planes.",{"measure":18,"description":19,"timeFrame":12},"Intraobserver and Interobserver Measurement Reliability","Assessment of consistency of repeated ultrasonographic skin-to-epidural distance measurements performed by experienced anesthesiologists.",{"measure":21,"description":22,"timeFrame":23},"Agreement Between Ultrasonographic Measurements and Epidural Needle Depth","Agreement between ultrasonographically measured skin-to-epidural distance and clinically measured epidural needle depth in participants undergoing epidural analgesia for routine clinical indications.","During epidural analgesia procedure performed as part of routine perioperative care",null,{"allocation":24,"interventionModel":24,"interventionModelDescription":24,"primaryPurpose":24,"observationalModel":26,"timePerspective":27,"maskingInfo":24},"COHORT","PROSPECTIVE","Epidural analgesia is an effective method for perioperative pain management in pediatric patients and is widely used to reduce postoperative pain and opioid requirements. In infants, however, epidural procedures may be technically challenging because spinal anatomical structures are smaller and continue to change during early development. Variability in vertebral anatomy, ligament thickness, and spinal cord termination level may increase the difficulty of predicting epidural depth during neuraxial procedures. Even small differences in needle depth may be clinically important in this age group.\n\nUltrasonography has become an increasingly important tool in pediatric regional anesthesia because it provides real-time visualization of spinal anatomy without radiation exposure or harmful effects on the body. Preprocedural ultrasonographic assessment may help identify anatomical landmarks and estimate epidural depth before needle insertion. Previous studies have demonstrated that ultrasound measurements may correlate with actual epidural needle depth in pediatric patients. However, available data regarding normative skin-to-epidural distance measurements in infants remain limited, particularly at different vertebral levels and with different ultrasound imaging planes.\n\nIn infants, identification of the epidural space using conventional loss-of-resistance techniques may be more difficult than in older children and adults because tissue resistance changes may be less distinct. In addition, spinal anatomy changes rapidly during infancy, and measurements obtained at one vertebral level may not reflect measurements at other levels. Evaluation of multiple vertebral levels and imaging planes may therefore provide more comprehensive anatomical information for pediatric epidural procedures.\n\nThis study is designed to evaluate ultrasonographic skin-to-epidural distance measurements at multiple lumbar and thoracolumbar vertebral levels in infants undergoing elective surgery under general anesthesia. Measurements will be obtained using two commonly used ultrasound imaging planes to better characterize epidural depth in this population. The study will also evaluate the relationship between ultrasonographic measurements and demographic characteristics such as age, body weight, height, and gestational age.\n\nUltrasonographic evaluations will be performed during routine perioperative preparation under general anesthesia without additional invasive intervention for study purposes. In participants who undergo epidural catheter placement as part of routine clinical management, ultrasonographic measurements will additionally be compared with clinically measured epidural needle depth. Findings from this study may contribute to the development of more reliable reference data for infant epidural procedures and may support safer and more individualized pediatric regional anesthesia practices.","Participants will be recruited from infants scheduled for elective surgical procedures at the operating rooms of the Department of Anesthesiology and Reanimation, Cerrahpaşa Faculty of Medicine, Istanbul University-Cerrahpaşa. The study population consists of infants undergoing routine perioperative evaluation under general anesthesia in a tertiary academic medical center.",[31],{"label":32,"type":24,"description":33,"interventionNames":34},"Infants Ungergoing Elective Surgery","Infants aged 0-12 months undergoing elective surgery under general anesthesia who will undergo ultrasonographic skin-to-epidural distance measurements during routine perioperative care.",[35,36],"Diagnostic Test: Ultrasonographic Assessment of Skin-to-Epidural Distance","Procedure: Epidural Catheter Placement for Clinical Indications",[38,43],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":24},"DIAGNOSTIC_TEST","Ultrasonographic Assessment of Skin-to-Epidural Distance","Infants aged 0 to 12 months undergoing elective surgery under general anesthesia will undergo ultrasonographic assessment of the distance between the skin and the epidural space. Measurements will be performed in the lateral decubitus position using a high-frequency linear ultrasound transducer with minimal probe pressure to avoid soft tissue compression. The distance will be evaluated at the intervertebral levels between the twelfth thoracic vertebra and the first lumbar vertebra, the first and second lumbar vertebrae, the second and third lumbar vertebrae, and the third and fourth lumbar vertebrae. Measurements will be obtained using both the paramedian sagittal oblique and transverse median ultrasound views. Two experienced anesthesiologists will independently perform the measurements. The probe will be removed and repositioned before repeat measurements. No needle insertion or epidural catheter placement will be performed as part of this intervention.",[32],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":24},"PROCEDURE","Epidural Catheter Placement for Clinical Indications","A subgroup of infants requiring epidural analgesia as part of routine perioperative care will undergo epidural catheter placement. Epidural catheterization will not be performed for research purposes and will only be undertaken when clinically indicated. Following ultrasonographic assessment and induction of general anesthesia, infants will be positioned in the lateral decubitus position. Epidural catheter placement will be performed according to standard institutional practice. The epidural space will be identified using the loss-of-resistance technique at the vertebral level selected by the attending anesthesiologist, and the depth from the skin to the epidural space will be recorded. Catheter insertion, confirmation of placement, and analgesic management will follow routine clinical protocols. Data from these procedures will be used to compare actual epidural depth with ultrasonographic measurements. No additional invasive procedures will be performed for study purposes.",[32],[49,53,56,58],{"name":50,"affiliation":51,"role":52},"Ayşe Çiğdem Tütüncü, MD, Professor","Istanbul University Cerrahpasa- Cerrahpasa Medical Faculty","STUDY_CHAIR",{"name":54,"affiliation":51,"role":55},"Pınar Kendigelen, MD, Professor","STUDY_DIRECTOR",{"name":57,"affiliation":51,"role":52},"Münevver Kayhan, MD",{"name":59,"affiliation":51,"role":60},"Bahar İnan, MD","PRINCIPAL_INVESTIGATOR",[62],{"name":63,"role":64,"phone":65,"phoneExt":24,"email":66},"Bahar Inan, MD","CONTACT","+905387352525","bahar.inan@iuc.edu.tr",[68],{"facility":69,"status":24,"city":70,"state":24,"zip":71,"country":72,"countryCode":24,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Istanbul University Cerrahpasa, Cerrahpasa Medical Faculty","Istanbul","34098","Turkey (Türkiye)",{"type":74,"coordinates":75},"Point",[76,77],28.94966,41.01384,{"lat":77,"lon":76},[80,81],{"name":63,"role":64,"phone":65,"phoneExt":24,"email":66},{"name":54,"role":64,"phone":82,"phoneExt":24,"email":83},"+905325868734","pinar.kendigelen@iuc.edu.tr",{"type":60,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Bahar İnan","Resident Physician, Department of Anesthesiology and Reanimation","100657975","evaluation-of-skin-to-epidural-distance-at-different-vertebral-levels-by-ultrasonography-in-infants-a-prospective-observational-study-100657975",false,"NCT07847762","Evaluation of Skin-to-Epidural Distance at Different Vertebral Levels by Ultrasonography in Infants: A Prospective Observational Study","Evaluation of Skin-to-Epidural Distance With Ultrasonography at Different Vertebral Levels in Infants: A Prospective Observational Study","Inclusion Criteria:\n\n* Infants aged 0 to 12 months\n* Scheduled for elective surgery under general anesthesia\n* American Society of Anesthesiologists physical status I to III\n* Written informed consent obtained from parents or legal guardians\n\nExclusion Criteria:\n\n* Known vertebral or spinal cord anomalies, including scoliosis or spina bifida\n* Previous spinal surgery\n* Neuromuscular disease or known spinal cord pathology\n* Congenital syndromes associated with systemic malformations\n* Severe pulmonary, cardiac, hemodynamic, or neurological instability\n* Emergency surgery\n* Unreliable or incomplete ultrasonographic measurement data due to technical difficulties\n* Absence of written informed consent from parents or legal guardians","ALL","1 Year",{"count":97,"type":98},100,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn about the distance between the skin and the epidural space in infants younger than 12 months. The epidural space is an area near the spinal cord where doctors can give pain medicine to help control pain during and after surgery. Epidural pain treatment can greatly reduce the amount of pain a child feels after surgery. Researchers will use ultrasound, a method that uses sound waves to create images inside the body and does not have harmful effects on the body, to measure this distance in babies having planned surgery under general anesthesia. General anesthesia is a medicine that keeps patients asleep during surgery.\n\nThe main questions this study aims to answer are: Does the distance between the skin and the epidural space change with a baby's age, weight, height, or gestational age? Are the measurements similar when ultrasound images are taken from different directions? How close are the ultrasound measurements to the actual depth reached by the needle in babies who receive epidural pain treatment as part of their regular medical care?\n\nParticipants will have ultrasound images taken after they are asleep under general anesthesia. Measurements will be taken at 4 different areas of the lower back and from 2 different viewing directions. The measurements will be performed by 2 experienced doctors. Each doctor will repeat the same measurements 2 times to check consistency. Participants will receive epidural pain treatment only if it is already planned as part of their usual care.\n\nNo extra invasive procedure or additional medication will be given for this study.",[102],"Ultrasonographic Evaluation of Epidural Depth in Infants",[104,105,106,107,108,109],"Infants","Epidural Distance","Pediatric Regional Anesthesia","Skin-to-Epidural Distance","Epidural Depth","Neuraxial Ultrasound","NOT_YET_RECRUITING","2026-09-23",{"date":113,"type":114},"2026-09-29","ACTUAL",{"date":116,"type":98},"2026-11-01",{"date":118,"type":98},"2027-11-01",{"name":5,"class":6},1]