[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614024":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":49,"collaborators":26,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":26,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Umraniye Education and Research Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Paragastric Block with Bupivacaine","EXPERIMENTAL","Participants in this group will undergo laparoscopic sleeve gastrectomy with intraoperative paragastric block. A total of 20 mL of 0.5% bupivacaine will be injected into six predefined anatomical sites around the stomach under direct laparoscopic visualization after gastric resection. The block targets autonomic nerve plexuses to reduce postoperative visceral pain and nausea. The injection will be performed using a standardized technique with a 25G needle.",[13],"Drug: Bupivacaine 0.5%",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Block with Isotonic Saline","PLACEBO_COMPARATOR","Participants in this group will undergo laparoscopic sleeve gastrectomy with a sham paragastric block. A total of 20 mL of isotonic saline will be injected into the same six anatomical sites using the same technique, timing, needle type, and volume as the intervention group, ensuring proper blinding. No active local anesthetic will be used.",[19],"Drug: Isotonic Saline (0.9% NaCl)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Bupivacaine 0.5%","Participants receive 20 mL of 0.5% bupivacaine administered intraoperatively as a paragastric block. The injection is performed under laparoscopic guidance at six predefined anatomical sites around the stomach following gastric resection.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Isotonic Saline (0.9% NaCl)","Participants receive 20 mL of isotonic saline (placebo) administered intraoperatively using the same injection technique and anatomical landmarks as the active treatment group, to maintain blinding.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Abdullah Sisik, MD, Professor of General Surgery","CONTACT","+905327252381","abdullahsisik@gmail.com",[38],{"facility":39,"status":40,"city":41,"state":26,"zip":26,"country":42,"countryCode":26,"cosmosGeoPoint":43,"geoPoint":48,"contacts":26},"Istanbul Gedik University","RECRUITING","Istanbul","Turkey (Türkiye)",{"type":44,"coordinates":45},"Point",[46,47],28.94966,41.01384,{"lat":47,"lon":46},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":39,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Abdullah Sisik","Professor of General Surgery","100614024","paragastric-block-for-pain-and-ponv-in-sleeve-gastrectomy-100614024",false,"NCT07274215","Paragastric Block for Pain and PONV in Sleeve Gastrectomy","Impact of Intraoperative Paragastric Block on Visceral Pain and Postoperative Nausea and Vomiting After Sleeve Gastrectomy: A Randomized Controlled Trial","BLOCK-SG","Inclusion Criteria\n\n* Patients aged between 18 and 65 years.\n* Candidates scheduled for elective LSG.\n* American Society of Anesthesiologists (ASA) physical status classification I-III.\n* Ability to provide written informed consent and willingness to comply with study procedures.\n\nExclusion Criteria\n\n* History of prior upper abdominal surgery.\n* Known psychiatric or neurological disorders that could interfere with pain assessment or postoperative care.\n* History of opioid dependency or chronic opioid use.\n* Allergy or hypersensitivity to local anesthetics or any of the medications used in the study protocol (e.g., paracetamol, dexketoprofen, ondansetron, tramadol, metoclopramide).\n* Severe hepatic, renal, or cardiac dysfunction (e.g., cirrhosis, end-stage renal disease, heart failure).\n* Pregnancy or breastfeeding.\n* Concomitant surgery (e.g., cholecystectomy, hiatal hernia repair, or abdominal wall repair).\n* Known bleeding disorders or coagulopathy (e.g., INR \\>1.5, platelet count \\\u003C50,000\u002Fmm³, or ongoing anticoagulant therapy)","ALL","18 Years","65 Years",{"count":65,"type":66},200,"ESTIMATED","INTERVENTIONAL",[69],"NA","This single-center, prospective, randomized, double-blind controlled trial aims to evaluate the effects of intraoperative paragastric block (PGBLOCK) on early postoperative visceral pain, postoperative nausea and vomiting (PONV), and analgesic requirements in patients undergoing laparoscopic sleeve gastrectomy (LSG). Despite advancements in multimodal analgesia protocols, visceral pain remains a significant postoperative concern following LSG, contributing to increased opioid use and delayed recovery. Paragastric block is a novel technique targeting autonomic neural pathways-such as branches of the celiac ganglia and vagal nerves-through precise intraoperative injection of local anesthetics near the stomach.\n\nA total of 180 patients scheduled for elective LSG will be randomized in a 1:1 ratio to receive either paragastric block with 20 mL of 0.5% bupivacaine or a sham block with 20 mL of isotonic saline. Injections will be administered at six predefined anatomical sites under laparoscopic guidance after gastric resection. The surgical technique, anesthetic protocol, and postoperative care will be standardized for all participants. Both patients and clinical personnel involved in care and outcome assessment will remain blinded to group assignment.\n\nThe primary outcome is the assessment of postoperative visceral pain using Visual Analog Scale (VAS) scores at 0 and 2 hours postoperatively. Secondary outcomes include PONV severity grading, mobilization status, total analgesic consumption (pethidine + tramadol), and need for rescue antiemetics within the first 24 hours post-surgery. Exclusion criteria include history of upper abdominal surgery, chronic opioid use, pregnancy, severe systemic disease, or allergy to medications used in the protocol.\n\nThis study is expected to provide high-quality evidence regarding the efficacy of paragastric block in improving early postoperative recovery and reducing opioid reliance after LSG.",[72,73],"Postoperative Nausea and Vomiting","Postoperative Pain After Laparoscopic Sleeve Gastrectomy",[75,76,77,78,79],"postoperative pain","postoperative nausea and vomiting","VAS","sleeve gastrectomy","paragastric block","2025-12-10",{"date":82,"type":83},"2025-12-18","ACTUAL",{"date":85,"type":83},"2025-10-01",{"date":87,"type":66},"2026-01-20",{"name":5,"class":6},1]