Paragastric block to reduce pain and nausea after sleeve gastrectomy
Impact of Intraoperative Paragastric Block on Visceral Pain and Postoperative Nausea and Vomiting After Sleeve Gastrectomy: A Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Umraniye Education and Research Hospital Government |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07274215 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Istanbul
- Istanbul Gedik University — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Abdullah Sisik, MD, Professor of General Surgery
- Email: abdullahsisik@gmail.com
- Phone: +905327252381
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.