[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640862":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":39,"studyPopulation":29,"armGroups":40,"interventions":53,"overallOfficials":64,"centralContacts":71,"locations":81,"responsibleParty":98,"collaborators":29,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":29,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":29,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":29,"overallStatus":84,"whyStopped":29,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Zagazig University","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Time to rescue analgesia","First time of additional analgesia given when the child exhibit moderate to severe pain with pain score become ≥ 4.","24 hours",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"Heart rate","The perioperative changes in heart rate basally and at time interval 10-minutes till discharge and at ward at 2,4,8,16, and 24 hours postoperative.",{"measure":18,"description":19,"timeFrame":12},"Mean arterial pressure","The perioperative changes in mean blood pressure basally and at time interval 10-minutes till discharge and at ward at 2,4,8,16, and 24 hours postoperative.",{"measure":21,"description":22,"timeFrame":12},"Postoperative pain score","Pain score will be assessed using the Face, Legs, Activity, Cry, and Consolability score immediately postoperative then at 2, 4, 8, 16 and 24 hours with a score of 0 indicates no pain and 10 indicates maximum pain.",{"measure":24,"description":25,"timeFrame":12},"Total dose of opioid consumption","The total dose of opioid consumption as rescue analgesia in the first 24 hours postoperative.",{"measure":27,"description":28,"timeFrame":12},"Parental satisfaction","Parental satisfaction will be evaluated using a five-point score at the end of the first 24 hours with a score of 5 indicate the highest satisfaction and 1 indicate the lowest satisfaction.",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":29,"whoMasked":36},"DOUBLE",[37,38],"PARTICIPANT","OUTCOMES_ASSESSOR","Effective postoperative pain control in pediatric patients remains a major concern, particularly in those undergoing anal, perineal and penile surgeries. Inadequate analgesia is associated with delayed recovery, increased stress response, prolonged hospitalisation, and higher postoperative morbidity. This study aims to evaluate the efficacy of ultrasound-guided sacral multifidus plane block as a method for perioperative analgesia in high-risk pediatric patients undergoing anorectal and penile surgeries, to reduce the risks associated with systemic analgesia. This involves the administration of local anesthetics in the plane between the sacral multifidus muscle and the intermediate sacral crest bilaterally.",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"Sacral Multifidus plane block group","ACTIVE_COMPARATOR","The patients will receive an ultrasound-guided sacral multifidus plane block after induction of general anesthesia.",[46],"Procedure: Sacral multifidus plane block",{"label":48,"type":49,"description":50,"interventionNames":51},"Control group","PLACEBO_COMPARATOR","The patients will receive systemic parenteral analgesia.",[52],"Other: Systemic analgesia",[54,59],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":29},"OTHER","Systemic analgesia","Patients will receive 10 milligrams per kilogram body weight of intravenous paracetamol every 8 hours and fentanyl 1 microgram per kilogram body weight intravenously as rescue analgesia.",[48],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":29},"PROCEDURE","Sacral multifidus plane block","Patients will receive an ultrasound-guided sacral multifidus plane block after induction of general anesthesia.",[42],[65,69],{"name":66,"affiliation":67,"role":68},"Abdelrazek yousef, MD","Department of Pediatric surgery, Zagazig University","PRINCIPAL_INVESTIGATOR",{"name":70,"affiliation":67,"role":68},"Mohamed Ismail Sabry, MD",[72,78],{"name":73,"role":74,"phone":75,"phoneExt":76,"email":77},"Abdalla Mohamed Goda Mohamed, MD","CONTACT","1114166085","+20","drabdogoda@gmail.com",{"name":79,"role":74,"phone":29,"phoneExt":29,"email":80},"Amira Attia Ebrahim Farag, MD","Amiraattia86@gmail.com",[82],{"facility":83,"status":84,"city":85,"state":29,"zip":29,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Zagazig university hospital","RECRUITING","Zagazig","Egypt","EG",{"type":89,"coordinates":90},"Point",[91,92],31.502,30.58768,{"lat":92,"lon":91},[95],{"name":96,"role":74,"phone":29,"phoneExt":29,"email":97},"Mohamed mohamed, MD","mgmelsayed@medicine.zu.edu.eg",{"type":99,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100640862","analgesia-for-perineal-surgeries-in-high-risk-pediatric-patients-100640862",false,"NCT07602894","Analgesia for Perineal Surgeries in High-risk Pediatric Patients","Efficacy of Ultrasound-guided Sacral Multifidus Plane Block as Perioperative Analgesia for Anal and Penile Surgeries in High-risk Pediatric Patients","Inclusion Criteria:\n\n* Parents or caregivers' acceptance.\n* High-risk pediatric patients (the American Society of Anesthesiologists physical status class III-IV)\n* Body mass index equal to 5%: 85% of the same age and sex.\n\nExclusion Criteria:\n\n* Child with a contraindication to the regional block, such as infection at the site of injection, or coagulopathy.\n* Pre-existing neurological disorders.","ALL","12 Months","12 Years",{"count":111,"type":112},60,"ESTIMATED","INTERVENTIONAL",[115],"NA","Perioperative pain management in pediatric patients, especially for anorectal and penile surgeries, presents significant challenges for anesthetists. Complications associated with systemic analgesia, such as respiratory issues, cardiovascular problems, and neurological effects, can be avoided by using regional anesthesia. This study aims to evaluate the effectiveness of Ultrasound-Guided Sacral Multifidus Plane Block as a method for perioperative analgesia in high-risk pediatric patients undergoing anorectal and penile surgeries, to reduce the risks associated with systemic analgesia.",[118],"Analgesia","2026-08-20",{"date":121,"type":122},"2026-08-24","ACTUAL",{"date":124,"type":122},"2026-07-20",{"date":126,"type":112},"2027-12",{"name":5,"class":6},1]