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Paragastric Block for Pain and PONV in Sleeve Gastrectomy

RecruitingNAAges 18 Years - 65 YearsAllUmraniye Education and Research Hospital
NCT07274215 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. A 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

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📋 Eligibility rules (as published)
Inclusion Criteria * Patients aged between 18 and 65 years. * Candidates scheduled for elective LSG. * American Society of Anesthesiologists (ASA) physical status classification I-III. * Ability to provide written informed consent and willingness to comply with study procedures. Exclusion Criteria * History of prior upper abdominal surgery. * Known psychiatric or neurological disorders that could interfere with pain assessment or postoperative care. * History of opioid dependency or chronic opioid use. * Allergy or hypersensitivity to local anesthetics or any of the medications used in the study protocol (e.g., paracetamol, dexketoprofen, ondansetron, tramadol, metoclopramide). * Severe hepatic, renal, or cardiac dysfunction (e.g., cirrhosis, end-stage renal disease, heart failure). * Pregnancy or breastfeeding. * Concomitant surgery (e.g., cholecystectomy, hiatal hernia repair, or abdominal wall repair). * Known bleeding disorders or coagulopathy (e.g., INR \>1.5, platelet count \<50,000/mm³, or ongoing anticoagulant therapy)
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What it tests

  • Bupivacaine 0.5%
  • Isotonic Saline (0.9% NaCl)
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Where

1 site
Istanbul Gedik University
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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