NCT07274215 Paragastric Block for Pain and PONV in Sleeve Gastrectomy

Eligibility & Interventions

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This trial targets 200 participants in total. It began in 2025-10-01 with a primary completion date of 2025-12-30.

Brief Summary

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 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. The 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. This 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.

Eligibility Criteria

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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