[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655384":3},{"organization":4,"outcomesModule":7,"designInfo":75,"detailedDescription":74,"studyPopulation":74,"armGroups":80,"interventions":86,"overallOfficials":92,"centralContacts":96,"locations":101,"responsibleParty":121,"collaborators":74,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":125,"sex":131,"minAge":132,"maxAge":74,"enrollmentInfo":133,"targetDuration":74,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":144,"overallStatus":104,"whyStopped":74,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Nīmes","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":44,"otherOutcomes":74},[9,13,16,19,22,25,28,31,33,35,38,41],{"measure":10,"description":11,"timeFrame":12},"Local pain post-injection","0-10 visual analog scale","Day 15",{"measure":14,"description":15,"timeFrame":12},"Local intolerance post-injection","Redness, edema, warmth, inflammation: Yes\u002Fno",{"measure":17,"description":18,"timeFrame":12},"Local neurological disturbances post-injection","Paresthesia, hypoesthesia: Yes\u002Fno",{"measure":20,"description":21,"timeFrame":12},"Allergic reactions post-injection","Rash, edema, urticaria: Yes\u002Fno",{"measure":23,"description":24,"timeFrame":12},"Heart rate","beats per minutes",{"measure":26,"description":27,"timeFrame":12},"Blood pressure","mm Hg",{"measure":29,"description":30,"timeFrame":12},"Loss of consciousness","Yes\u002Fno",{"measure":32,"description":30,"timeFrame":12},"Seizures",{"measure":34,"description":30,"timeFrame":12},"Nausea and vomiting",{"measure":36,"description":37,"timeFrame":12},"Blood gluose level","mmol\u002FL",{"measure":39,"description":40,"timeFrame":12},"Post-parotidectomy facial nerve function alteration post-injection","Facial paralysis or facial nerve damage: Yes\u002Fno",{"measure":42,"description":43,"timeFrame":12},"Injection site damage","Hematoma or infection: Yes\u002Fno",[45,49,51,53,55,57,59,61,62,64,67,69,71],{"measure":46,"description":47,"timeFrame":48},"Postoperative pain","Measure on a 0-10 visual analog scale","Day 0",{"measure":46,"description":47,"timeFrame":50},"Day 1",{"measure":46,"description":47,"timeFrame":52},"Day 2",{"measure":46,"description":47,"timeFrame":54},"Day 4",{"measure":46,"description":47,"timeFrame":56},"Day 6",{"measure":46,"description":47,"timeFrame":58},"Day 9",{"measure":46,"description":47,"timeFrame":60},"Day 12",{"measure":46,"description":47,"timeFrame":12},{"measure":63,"description":30,"timeFrame":12},"Prevalence of salivary fistulas or sialomas",{"measure":65,"description":66,"timeFrame":12},"wound dehiscence","yes\u002Fno",{"measure":68,"description":30,"timeFrame":12},"inflammation of wound",{"measure":70,"description":30,"timeFrame":12},"infection of wound",{"measure":72,"description":73,"timeFrame":48},"Feasibility of bupivacaine\u002Fdexamethasone","Successful administion of bupivacaine\u002Fdexamethasone injection: Yes\u002Fno",null,{"allocation":76,"interventionModel":77,"interventionModelDescription":74,"primaryPurpose":6,"observationalModel":74,"timePerspective":74,"maskingInfo":78},"NA","SINGLE_GROUP",{"masking":79,"maskingDescription":74,"whoMasked":74},"NONE",[81],{"label":82,"type":83,"description":74,"interventionNames":84},"Patients who undergoing partial parotidectomy","EXPERIMENTAL",[85],"Drug: Intraparotid injection of bupivacaine\u002F dexamethasone",[87],{"type":88,"name":89,"description":90,"armGroupLabels":91,"otherNames":74},"DRUG","Intraparotid injection of bupivacaine\u002F dexamethasone","* 20 ml of 0.5% bupivacaine (5 mg\u002FmL), i.e., a dose of 100 mg;\n* 0.5 ml of dexamethasone (4 mg\u002FmL), i.e., a dose of 2 mg.",[82],[93],{"name":94,"affiliation":5,"role":95},"Benjamin Lallemant","PRINCIPAL_INVESTIGATOR",[97],{"name":94,"role":98,"phone":99,"phoneExt":74,"email":100},"CONTACT","04.66.68.36.85","benjamin.lallemant@chu-nimes.fr",[102],{"facility":103,"status":104,"city":105,"state":74,"zip":106,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":115},"Centre Hospitalier de Nimes","RECRUITING","Nîmes","30000","France","FR",{"type":110,"coordinates":111},"Point",[112,113],4.35788,43.83665,{"lat":113,"lon":112},[116,120],{"name":117,"role":98,"phone":118,"phoneExt":74,"email":119},"Anissa Megzari","04.66.68.42.36","drc@chu-nimes.fr",{"name":94,"role":95,"phone":74,"phoneExt":74,"email":74},{"type":122,"investigatorFullName":74,"investigatorTitle":74,"investigatorAffiliation":74,"oldNameTitle":74,"oldOrganization":74},"SPONSOR","100655384","early-phase-1-clinical-tolerance-of-an-intraparotid-injection-of-bupivacaine-combined-with-dexamethasone-after-parotidectomy-for-benign-tumor-100655384",false,"NCT07812259","Clinical Tolerance of an Intraparotid Injection of Bupivacaine, Combined With Dexamethasone, After Parotidectomy for Benign Tumor","Evaluation of the Clinical Tolerance of an Intraparotid Injection of Bupivacaine, Combined With Dexamethasone, After Parotidectomy for Benign Tumor - A Single-center Prospective Cohort Study.","PAROCAINE","Inclusion Criteria:\n\n* Validated surgical indication for partial parotidectomy for parotid tumor.\n* The patient must have given their free and informed consent and signed the consent form\n* The patient must be a member or beneficiary of a health insurance plan\n\nExclusion Criteria:\n\n* The subject is in a period of exclusion determined by a previous study\n* The patient is under safeguard of justice or state guardianship\n* History of allergic reaction to amino-amide-type local anesthetics.\n* Severe neurological history (epilepsy, peripheral neuropathies).\n* High-risk cardiovascular history (severe hypertension, arrhythmias, complete or incomplete heart block, heart failure, coronary artery disease, treatment with type 2 antiarrhythmic drugs).\n* Severe liver or kidney disease (severe liver failure or severe kidney failure).\n* Acidosis, sepsis.\n* Pregnant or breastfeeding patient.\n* Patient unable to give informed consent.\n* Patient for whom it is impossible to provide informed consent.","ALL","18 Years",{"count":134,"type":135},10,"ESTIMATED","INTERVENTIONAL",[138],"EARLY_PHASE1","There has been a paradigm shift toward less invasive surgical techniques for parotidectomies, primarily to mitigate post-surgical complications. However, preserving more parotid tissue than with traditional methods can lead to an increased incidence of salivary fistulas and sialoceles after parotidectomy. The incidence of sialoceles varies considerably from 4.9% to 39%, while salivary fistula rates after parotidectomy range from 1% to 21%. Other wound complications, such as wound dehiscence, inflammation, and infection, can also occur, typically within the first month following surgery. No preventive technique has yet demonstrated clear efficacy or superiority in clinical practice.\n\nBupivacaine is an amino-amide commonly used for local anesthesia. With its long-acting anesthetic effects, bupivacaine blocks the autonomic pathways (parasympathetic and sympathetic), then the sensory pathways, and finally the motor pathways. By providing prolonged blockade of the parasympathetic nerve pathways that induce salivary secretion, bupivacaine injected into the parotid tissue during surgery could be a potentially effective prophylactic agent for preventing salivary fistulas after parotidectomy. Certain adjuvants can be used locally in combination with bupivacaine to prolong the duration of nerve blocks and improve postoperative pain management. Dexamethasone is the most effective adjuvant to long-acting local anesthetics. This combination is widely used in routine practice.\n\nDue to its sustained blockade of parasympathetic nerve fibers, intraparotid bupivacaine, combined with local dexamethasone, could be an effective tool for reducing various postoperative complications, including sialoceles and salivary fistulas, after partial parotidectomy. It could also play a major role in postoperative analgesia. Although bupivacaine is commonly used in surgical practice, there are no data regarding the injection of bupivacaine combined with dexamethasone into the parotid tissue to prevent salivary complications after partial parotidectomy. Therefore, the safety of its use when injected specifically into the parotid tissue has never been evaluated.\n\nThe aim of this pilot study is to assess the tolerability of intraparotid injection of bupivacaine combined with a local injection of dexamethasone after partial parotidectomy for a benign tumor.",[141,142,143],"Parotid Neoplasm","Bupivacaine","Dexamethasone",[145],"Drug tolerance","2026-09-04",{"date":148,"type":149},"2026-09-10","ACTUAL",{"date":151,"type":149},"2026-05-18",{"date":153,"type":135},"2027-06",{"name":5,"class":6},1]