Paragastric block to reduce pain and nausea after sleeve gastrectomy
Official title: Impact of Intraoperative Paragastric Block on Visceral Pain and Postoperative Nausea and Vomiting After Sleeve Gastrectomy: A Randomized Controlled Trial
Run by Umraniye Education and Research Hospital · NCT07274215 · Data updated 2026-11-12
This trial will test whether giving a paragastric block during laparoscopic sleeve gastrectomy reduces early visceral pain, postoperative nausea and vomiting, and opioid needs in adults having elective LSG.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Umraniye Education and Research Hospital Government |
| Locations | 1 site (Istanbul) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | December 30, 2025 |
| Study ends | January 20, 2026 |
| Registry record updated | December 18, 2025 |
| Trial ID | NCT07274215 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with ASA physical status I–III who are scheduled for elective laparoscopic sleeve gastrectomy and can provide informed consent are the intended participants.
✕Probably not a fit
Patients with prior upper abdominal surgery, chronic opioid dependence, severe hepatic/renal/cardiac dysfunction, allergy to local anesthetics, pregnancy or breastfeeding, concurrent abdominal procedures, or coagulopathy are excluded and unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, prospective, randomized, double-blind controlled trial will enroll 180 adults undergoing elective laparoscopic sleeve gastrectomy and randomize them 1:1 to receive either a paragastric block with 20 mL 0.5% bupivacaine or a sham block with 20 mL saline injected at six predefined intraoperative sites. Pain will be measured using visual analog scales for early postoperative visceral pain, and PONV and analgesic consumption will be recorded in the immediate postoperative period. The injections target autonomic neural plexuses around the stomach, including branches of the celiac ganglia and vagal pathways, to address visceral pain that often persists despite somatic-focused multimodal analgesia. Outcomes will compare pain scores, incidence of PONV, and opioid requirements between groups under a double-blind protocol.
Why it matters
Potential benefit: If effective, the paragastric block could reduce early postoperative visceral pain, lower opioid use, and decrease nausea and vomiting after sleeve gastrectomy.
How similar studies have gone: Paragastric block is a relatively novel, targeted technique with limited prior clinical data; small reports suggest potential benefit but large randomized evidence is currently lacking.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
Istanbul Gedik University
Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Abdullah Sisik, MD, Professor of General Surgery
- Email: abdullahsisik@gmail.com
- Phone: +905327252381
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.