Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07274215

Paragastric Block for Pain and PONV in Sleeve Gastrectomy

Led by Umraniye Education and Research Hospital · Updated on 2025-12-18

200

Participants Needed

1

Research Sites

15 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Paragastric Block for Pain and PONV in Sleeve Gastrectomy

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged between 18 and 65 years.
  • Candidates scheduled for elective laparoscopic sleeve gastrectomy (LSG).
  • American Society of Anesthesiologists (ASA) physical status classification I-III.
  • Ability to provide written informed consent and willingness to comply with study procedures.
Not Eligible

You will not qualify if you...

  • 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 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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Istanbul Gedik University

Istanbul, Turkey (Türkiye)

Actively Recruiting

Loading map...

Research Team

A

Abdullah Sisik, MD, Professor of General Surgery

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here