[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543258":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":36,"studyPopulation":26,"armGroups":37,"interventions":56,"overallOfficials":70,"centralContacts":75,"locations":84,"responsibleParty":102,"collaborators":26,"id":104,"slug":26,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":105,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":26,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":124,"overallStatus":87,"whyStopped":26,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Hamilton Health Sciences Corporation","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Post-operative pain score","Pain score, measured by visual analog scale (scale of 0-10) at 6, 12 and 24 hours post-op","through study completion, approximately 1 year",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Post-operative bleeding","amount of post-op bleeding (mL) in first 24 hours",{"measure":18,"description":19,"timeFrame":12},"Post-operative complications","record presence of post-op nausea\u002Fvomiting, headache, sore throat, difficulty swallowing in first 24 hours",{"measure":21,"description":22,"timeFrame":12},"Analgesic requirement","List and dose of analgesics administered to patient in first 24 hours or time of discharge, whichever comes first",{"measure":24,"description":25,"timeFrame":12},"Length of stay","Length of hospital stay in hours",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":33},"DOUBLE",[34,35],"PARTICIPANT","OUTCOMES_ASSESSOR","To further improve the quality of the early postoperative course, the investigators propose the use of the sphenopalatine ganglion (SPG) block (SPGB) for pain management in the context of an enhanced recovery after surgery (ERAS) protocol for minimally invasive (MIS) endoscopic transsphenoidal pituitary surgery. The SPG is the main sensory innervation to the nasal mucosa, and several studies have shown the analgesic efficacy of SPGB following sinus surgery and showed positive results for endoscopic sinus surgery. However, there is limited research on the use of SPGB in the context of pituitary surgery.\n\nIn this randomized placebo-controlled trial, the investigators aim to assess the benefit of SPGB with bupivacaine in addition to multimodal general anesthesia on pain management, after MIS pituitary surgery. The results of the trial will provide valuable insights into the potential benefits of SPGB and its optimal use for pituitary surgery.",[38,44,50],{"label":39,"type":40,"description":41,"interventionNames":42},"Bupivacaine injection","EXPERIMENTAL","This group will receive bilateral injection of 0.5% bupivacaine with 1:200,000 epinephrine using a 20G needle and comprising 2mL of fluid on each side (4mL total) into the sphenopalatine ganglion.",[43],"Drug: Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution",{"label":45,"type":46,"description":47,"interventionNames":48},"Placebo Control","PLACEBO_COMPARATOR","This group will receive bilateral injection of 0.9% saline solution using a 20G needle and comprising 2mL of fluid on each side (4mL total) into the sphenopalatine ganglion.",[49],"Drug: Placebo",{"label":51,"type":52,"description":53,"interventionNames":54},"Sham - no injection","SHAM_COMPARATOR","Participants randomized to this arm will not receive any additional study injections and will undergo the current standard procedure for patients undergoing endoscopic endonasal surgery.",[55],"Drug: Sham Comparator",[57,62,66],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":26},"DRUG","Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution","2mL injection bilateral (4mL total) of 0.5% bupivacaine with 1:200,000 epinephrine solution, 20G needle, sterile, sphenopalatine ganglion; nerve block",[39],{"type":58,"name":63,"description":64,"armGroupLabels":65,"otherNames":26},"Placebo","2mL injection bilateral (4mL total) 0.9% saline solution, 20G needle, sterile, sphenopalatine ganglion; nerve block",[45],{"type":58,"name":67,"description":68,"armGroupLabels":69,"otherNames":26},"Sham Comparator","Participants receive no additional study injections",[51],[71],{"name":72,"affiliation":73,"role":74},"Dr. Kesava Reddy, MD","Hamilton Health Sciences Corporatin","PRINCIPAL_INVESTIGATOR",[76,80],{"name":72,"role":77,"phone":78,"phoneExt":26,"email":79},"CONTACT","905-521-2100","reddy@hhsc.ca",{"name":81,"role":77,"phone":82,"phoneExt":26,"email":83},"Ms. Jessy Moore, MSc","289-686-8827","moorej@hhsc.ca",[85],{"facility":86,"status":87,"city":88,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"Hamilton General Hospital","RECRUITING","Hamilton","Ontario","L8L 2X2","Canada","CA",{"type":94,"coordinates":95},"Point",[96,97],-79.84963,43.25011,{"lat":97,"lon":96},[100,101],{"name":72,"role":77,"phone":78,"phoneExt":26,"email":79},{"name":81,"role":77,"phone":82,"phoneExt":26,"email":83},{"type":103,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100543258",false,"NCT06353529","Postop Pain Management in Pituitary Tumour Patients","Effect of Sphenopalatine Ganglion Block With Bupivacaine on Postoperative Pain in Patients Undergoing Endoscopic Pituitary Adenoma Resection","POPPY","Inclusion Criteria:\n\n* adult patients (18 yrs or older)\n* undergoing endonasal pituitary adenoma resection\n\nExclusion Criteria:\n\n* Patients with pre-existing chronic pain conditions requiring antidepressants (serotonin reuptake inhibitors), benzodiazepines, gabapentin, or opioid drugs\n* contraindications to the performance of SPGB such as known allergy to used medications\n* chronic alcohol abuse\n* uncontrolled systemic arterial hypertension\n* severe kidney or liver diseases\n* cardiomyopathies or sustained cardiac arrhythmias (permanent paroxystic atrial fibrillation or other sustained supraventricular rhythmic anomalies)","ALL","18 Years","100 Years",{"count":115,"type":116},108,"ESTIMATED","INTERVENTIONAL",[119],"PHASE4","To assess the benefit of using an additional nerve block during minimally invasive pituitary surgery, to improve pain management after surgery. The medication (Bupivacaine) or a placebo (saline) will be injected during surgery and patients will be asked about their level of pain at multiple time points in the first 24 hours following surgery. Some patients will be randomized to a third, sham group that do not receive any additional injection. The aim is to improve patient outcomes and reduce the need for pain medication after surgery.",[122,123],"Pituitary","Pain, Postoperative",[125,126,127],"Nerve block","Bupivacaine","Sphenopalatine Ganglion","2026-03-10",{"date":130,"type":131},"2026-03-12","ACTUAL",{"date":133,"type":131},"2024-11-25",{"date":135,"type":116},"2026-07",{"name":5,"class":6},1]