[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641306":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":19,"responsibleParty":34,"collaborators":19,"id":36,"slug":19,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":19,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":19,"enrollmentInfo":44,"targetDuration":19,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":60,"whyStopped":19,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":19},{"fullName":5,"class":6},"Universidad Simón Bolívar","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Catheter Re-dosing for Breakthrough Symptoms After LSG","EXPERIMENTAL","Participants with breakthrough symptoms, defined as visceral pain of 4\u002F10 or higher, postoperative nausea, or vomiting, will receive 15 mL of bupivacaine 0.5% plus dexamethasone 4 mg through the temporary catheter. Symptom response will be recorded 15 minutes after administration. Catheter re-dosing may be repeated if breakthrough visceral\u002Fautonomic symptoms recur, provided that at least 8 hours have elapsed since the prior dose and the participant remains under direct institutional supervision. The catheter will be removed 24 hours postoperatively or before hospital discharge, whichever occurs first.",[13],"Other: Bupivacaine 0.5% and Dexamethasone via Temporary Catheter",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Bupivacaine 0.5% and Dexamethasone via Temporary Catheter","Autonomic neural blockade (ANB) re-dosing will be performed by administering bupivacaine 0.5% and dexamethasone through a temporary catheter placed in the paragastric area during laparoscopic sleeve gastrectomy",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Jorge Daes, MD","clinica Iberoamerica","PRINCIPAL_INVESTIGATOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},"CONTACT","+57 3106363636","jorgedaez@gmail.com",{"name":31,"role":27,"phone":32,"phoneExt":19,"email":33},"Daniel Garcia De La Rosa, MD","+57 3138510029","dr.danielgarciadlr@gmail.com",{"type":35,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100641306",false,"NCT07655908","Catheter Redosing of Autonomic Neural Blockade After Sleeve Gastrectomy","Targeted Temporary In Situ Catheter Redosing of Autonomic Neural Blockade for Breakthrough Symptoms After Laparoscopic Sleeve Gastrectomy","Inclusion Criteria:\n\nPatients undergoing elective laparoscopic sleeve gastrectomy with one or more of the following risk factors for breakthrough visceral\u002Fautonomic symptoms:\n\n* Female sex age \\\u003C30 years\n* Prior history of severe postoperative pain after abdominal surgery\n* Prior history of significant postoperative nausea\u002Fvomiting\n* History of opioid intolerance or significant opioid-related adverse effects\n* Allergy\u002Fintolerance to multiple postoperative analgesics\u002Fantiemetics\n* Concomitant hiatal hernia repair\n* Surgeon's judgment of elevated visceral symptom risk based on prior institutional experience\n\nExclusion Criteria:•\n\n* Contraindication to local anesthetics or dexamethasone\n* Chronic opioid dependence\n* Severe psychiatric or cognitive impairment limiting symptom assessment\n* Pregnancy\n* Conversion to open surgery\n* Inability or unwillingness to comply with the postoperative reporting protocol.","ALL","18 Years",{"count":45,"type":46},30,"ESTIMATED","INTERVENTIONAL",[49],"NA","Postoperative visceral pain and autonomic symptoms after laparoscopic sleeve gastrectomy may reappear earlier in selected high-risk patients despite standard intraoperative autonomic neural blockade (ANB). Temporary in situ catheter placement permits postoperative ANB redosing when breakthrough visceral symptoms occur.\n\nThis prospective single-arm observational study will evaluate the feasibility, safety, and clinical effectiveness of temporary ANB catheter placement and selective postoperative redosing in high-risk patients undergoing laparoscopic sleeve gastrectomy.",[52,53],"Pain, Acute Post-Operative","Nausea and Vomiting, Postoperative",[55,56,57,58,59],"Autonomic neural blockade","visceral pain","postoperative nausea and vomiting","re-dosing","temporal catheter","NOT_YET_RECRUITING","2026-06-13",{"date":63,"type":64},"2026-06-18","ACTUAL",{"date":66,"type":46},"2026-06-15",{"date":68,"type":46},"2027-02",{"name":5,"class":6}]