[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608196":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":11,"centralContacts":39,"locations":45,"responsibleParty":63,"collaborators":11,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":11,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":11,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":48,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Benha University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A - Ultrasound-Guided Spinal Anesthesia (No Sedation)","ACTIVE_COMPARATOR",null,[13],"Procedure: Ultrasound-guided spinal anesthesia",{"label":15,"type":16,"description":11,"interventionNames":17},"Arm B - Ultrasound-Guided Spinal Anesthesia with Sedation (Midazolam)","EXPERIMENTAL",[18],"Drug: Midazolam plus ultrasound-guided spinal anesthesia",{"label":20,"type":21,"description":11,"interventionNames":22},"Arm C - Landmark-Guided Spinal Anesthesia (Control)","PLACEBO_COMPARATOR",[23],"Procedure: Landmark-guided spinal anesthesia",[25,30,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"PROCEDURE","Ultrasound-guided spinal anesthesia","Spinal anesthesia performed under real-time ultrasound guidance using a curvilinear ultrasound probe and 25-27G pencil-point spinal needle. Intrathecal injection of bupivacaine 0.5% hyperbaric (12-15 mg) following local infiltration with lidocaine 1% (2-3 mL).",[9],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"DRUG","Midazolam plus ultrasound-guided spinal anesthesia","Patients will receive midazolam (0.02-0.05 mg\u002Fkg IV; max 5 mg) 5-10 minutes prior to spinal anesthesia. Ultrasound guidance used for spinal needle placement. Intrathecal bupivacaine 0.5% hyperbaric (12-15 mg) after lidocaine 1% (2-3 mL) infiltration. Oxygen supplementation at 2 L\u002Fmin and standard monitoring.",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":11},"Landmark-guided spinal anesthesia","Spinal anesthesia performed using the traditional landmark palpation technique without ultrasound guidance or sedation. Intrathecal bupivacaine 0.5% hyperbaric (12-15 mg) after lidocaine 1% (2-3 mL) infiltration, using a 25-27G pencil-point spinal needle.",[20],[40],{"name":41,"role":42,"phone":43,"phoneExt":11,"email":44},"Samar R Amin, M.D.","CONTACT","+201287793991","samar.rafik@gmail.com",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Benha University Hospital","RECRUITING","Banhā","Qalyubia Governorate","13511","Egypt","EG",{"type":55,"coordinates":56},"Point",[57,58],31.1842,30.45977,{"lat":58,"lon":57},[61],{"name":62,"role":42,"phone":43,"phoneExt":11,"email":44},"Samar R Amin, MD",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Samar Rafik Mohamed Amin","Assistant professor of anesthesia and intensive care","100608196","effect-of-sedation-after-ultrasound-guided-spinal-anesthesia-on-back-pain-100608196",false,"NCT07198412","Effect of Sedation After Ultrasound-Guided Spinal Anesthesia on Back Pain","Impact of Ultrasound-Guided Spinal Anesthesia and Pre-Procedure Sedation on Postoperative Acute and Chronic Back Pain in Non-Obstetric Surgery.","Inclusion Criteria\n\nAdults aged 18-65 years ASA physical status I-II Body Mass Index (BMI) ≤ 35 kg\u002Fm² Scheduled for elective non-obstetric lower abdominal or lower limb surgery under spinal anesthesia Able to provide written informed consent\n\nExclusion Criteria\n\nContraindications to spinal anesthesia (e.g., coagulopathy, local infection at puncture site) Pre-existing chronic low back pain Chronic opioid use Known allergy or contraindication to study medications (bupivacaine, lidocaine, midazolam) Psychiatric or neurological disorders affecting pain perception or reporting Severe spinal deformities or history of previous spinal surgery Inability to comply with follow-up assessments","ALL","18 Years","65 Years",{"count":78,"type":79},180,"ESTIMATED","INTERVENTIONAL",[82],"NA","This study will evaluate whether giving sedation before spinal anesthesia, when performed with ultrasound guidance, reduces the risk of developing back pain after surgery. Spinal anesthesia is commonly used but may cause discomfort or persistent back pain in some patients. By comparing standard techniques, ultrasound guidance, and sedation, we aim to find safer and more comfortable approaches for patients undergoing non-obstetric surgery.",[85,86,87],"Pain Management","Postoperative Acute Pain","Chronic Back Pain",[89,90,91,92,93],"Spinal anesthesia","Ultrasound-guided anesthesia","Pre-procedure sedation","Midazolam","Chronic back pain","2025-11-14",{"date":96,"type":97},"2025-11-17","ACTUAL",{"date":99,"type":97},"2025-10-01",{"date":101,"type":79},"2026-05-10",{"name":5,"class":6},1]