[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617890":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":18,"responsibleParty":25,"collaborators":18,"id":27,"slug":18,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":18,"eligibilityCriteria":32,"healthyVolunteers":28,"sex":33,"minAge":34,"maxAge":35,"enrollmentInfo":36,"targetDuration":18,"studyType":39,"phases":40,"briefSummary":42,"conditions":43,"keywords":48,"overallStatus":50,"whyStopped":18,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":18},{"fullName":5,"class":6},"Pontificia Universidad Catolica de Chile","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intravenous dexamethasone","ACTIVE_COMPARATOR","cccc",[13],"Drug: administration of dexamethasone intravenously",{"label":15,"type":16,"description":17,"interventionNames":18},"Local dexamethasone","NO_INTERVENTION","ccc",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","administration of dexamethasone intravenously","IV dexamethasone administration will be added to the interscalene block. In the control group, dexamethasone will be applied perineurally.",[9],{"type":26,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100617890",false,"NCT07324499","Effect of Dexamethasone on Plasma Levels of Bupivacaine and Dexamethasone After a Single-injection Interscalene Nerve Block.","Effect of Dexamethasone on Plasma Levels of Bupivacaine and Dexamethasone Following a Single-injection Interscalene Nerve Block: A Randomized Controlled Study","Inclusion Criteria:\n\n\\- ASA I-II patients, with a body mass index (BMI) between 20 and 34 kg\u002Fm2 scheduled for shoulder surgery requiring single-needle interscalene block\n\nExclusion Criteria:\n\n\\- Chronic opioid use, liver failure, kidney failure, allergy to protocol drugs","ALL","18 Years","90 Years",{"count":37,"type":38},40,"ESTIMATED","INTERVENTIONAL",[41],"NA","Recent studies have highlighted the comparative advantages of perineural dexamethasone, particularly regarding its safety profile and its ability to prolong analgesia in various peripheral nerve blocks. A recent systematic review demonstrated that perineural administration of dexamethasone significantly extends the duration of analgesia compared to intravenous administration.\n\nThe mechanism of action of perineural dexamethasone remains unclear. Moreover, there is a lack of research comparing the systemic absorption of local anesthetics administered perineurally with or without dexamethasone, and the systemic absorption and bioavailability of dexamethasone when used as a perineural adjuvant have not been studied.\n\nObjective: This study aims to compare plasma concentrations of bupivacaine following a single-shot interscalene block with dexamethasone administered either perineurally or intravenously.\n\nMethodology: A prospective, randomized, double-blind trial will be conducted involving 40 patients undergoing shoulder surgery requiring a single-shot interscalene block. Each patient will receive 20 mL of 0.25% bupivacaine combined with 8 mg of dexamethasone administered either perineurally or intravenously. Venous blood samples (5 mL) will be collected at 5, 10, 20, 40, 80, 120, and 240 minutes post-block, and one sample at discharge, to measure plasma concentrations of both enantiomers of bupivacaine (D(+)-bupivacaine and L(-)-bupivacaine) and dexamethasone.\n\nOutcomes: The study will compare plasma levels of bupivacaine between groups, characterize the pharmacokinetics of bupivacaine and dexamethasone, and assess block duration and opioid consumption.",[44,45,46,47],"Pain","Interscalene Blocks","Dexamethasone","Bupivacaine",[46,47,44,49],"Interscalene blocks","NOT_YET_RECRUITING","2025-12-30",{"date":53,"type":54},"2026-01-07","ACTUAL",{"date":56,"type":38},"2026-03-01",{"date":58,"type":38},"2027-12-01",{"name":5,"class":6}]