[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100336970":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":27,"locations":39,"responsibleParty":53,"collaborators":27,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":27,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":27,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":80,"whyStopped":27,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"National Institute of Mental Health and Neuro Sciences, India","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Scalp & TAP Block (Group T)","EXPERIMENTAL","Group T received 0.2% Ropivacaine + clonidine 1µg\u002Fkg mixture, for ipsilateral scalp block (10ml),TAP block under USG guidance (20ml) and intravenous saline 0.1ml\u002Fkg\u002Fhr (sham infusion) for continuous infusion.",[13,14],"Procedure: Unilateral Scalp Block","Procedure: Transversus abdominis plane block",{"label":16,"type":17,"description":18,"interventionNames":19},"Intravenous Fentanyl (Group C)","ACTIVE_COMPARATOR","Group C received saline, for ipsilateral scalp block (10ml) and TAP block under USG guidance (20ml) and I.V fentanyl 1 µg\u002Fkg\u002Fhr as analgesic.",[20],"Drug: Intravenous Fentanyl",[22,28,34],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Unilateral Scalp Block","Scalp block is provided by injecting local anaesthetic in the scalp at specific areas to block 6 nerves which are responsible for sensory innervation of the scalp - Supraorbital and supratrochlear nerves, Zygomaticotemporal nerve, Auriculotemporal nerve, Greater and lesser occipital nerves.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Transversus abdominis plane block","The transverse abdominis plane (TAP) block is a peripheral nerve block designed to anesthetize the nerves supplying the anterior abdominal wall (T6 to L1). It is usually accomplished by a single bolus injection into the transversus abdominis plane through the lumbar triangle of Petit and can be accomplished either by blind landmark based technique or alternatively under ultrasound guidance (as in this study).",[9],[33],"TAP block",{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":27},"DRUG","Intravenous Fentanyl","Fentanyl is a commonly used opioid drug administered for analgesia in the perioperative period. It may be used as either intermittent bolus administration or continuous infusion or a combination of the two. Usual infusion doses range from 1-2 microgram\u002Fkg\u002Fhr, which may be titrated based on intraoperative haemodynamics or postoperative patient reported pain scores.",[16],[40],{"facility":41,"status":27,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":27},"Yashoda Hospitals","Secunderabad","Telangana","500003","India","IN",{"type":48,"coordinates":49},"Point",[50,51],78.54263,17.50427,{"lat":51,"lon":50},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"SPONSOR_INVESTIGATOR","Dhritiman Chakrabarti","Assistant Professor","100336970","phase-4-efficacy-of-scalp-block-and-ultrasound-guided-tap-block-with-clonidine-as-adjuvant-to-ropivacaine-versus-intravenous-fentanyl-on-intraoperative-hemodynamics-and-perioperative-analgesia-in-abdominal-bone-flap-cranioplasties-100336970",false,"NCT03667352","Efficacy Of Scalp Block And Ultrasound Guided TAP Block With Clonidine As Adjuvant To Ropivacaine Versus Intravenous Fentanyl On Intraoperative Hemodynamics And Perioperative Analgesia In Abdominal Bone Flap Cranioplasties","Efficacy Of Scalp Block And Ultrasound Guided TAP Block With Clonidine As Adjuvant To Ropivacaine Versus Intravenous Fentanyl On Intraoperative Hemodynamics And Perioperative Analgesia In Abdominal Bone Flap Cranioplasties: A Prospective, Randomised, Double Blind Study","Inclusion Criteria:\n\nPatients undergoing Abdominal bone flap replacement.\n\nExclusion Criteria:\n\n1. Motor and comprehensive aphasia,\n2. Disoriented mental state or Inability to follow commands.\n3. Hypersensitivity to amide local anesthetics,\n4. Bone flap site infection\n5. Coagulation disorders","ALL","18 Years","65 Years",{"count":68,"type":69},60,"ACTUAL","INTERVENTIONAL",[72],"PHASE4","This study assesses efficacy of scalp block and Ultrasound guided transverse abdominis plane (TAP) block with 1µg\u002Fkg clonidine as adjuvant to 0.2% ropivacaine versus intravenous fentanyl (0.1µg\u002Fkg\u002Fhr) on intraoperative hemodynamics and perioperative analgesia in abdominal bone flap cranioplasties (ABFC).",[75],"Condition: Abdominal Bone Flap Cranioplasty; Focus of Study: Perioperative Analgesia",[77,29,78,79],"Scalp block","Ropivacaine","Clonidine","COMPLETED","2018-09-12",{"date":83,"type":69},"2018-09-14",{"date":85,"type":69},"2017-07-15",{"date":87,"type":69},"2018-05-15",{"name":55,"class":6},1]