Paragastric Block for Pain and PONV in Sleeve Gastrectomy

NCT07274215 | Recruiting

• 1 other identifier: 186123-20.06.2025
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting; Postoperative Pain After Laparoscopic Sleeve Gastrectomy

Keywords

postoperative pain; postoperative nausea and vomiting; VAS; sleeve gastrectomy; paragastric block

Outcome Measures

Primary Outcomes (1)

• Visceral pain score measured by Visual Analog Scale (VAS)

  Postoperative visceral pain will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores will be recorded by blinded observers at specific postoperative time points.

  At 0 and 2 hours postoperatively

Secondary Outcomes (4)

• Postoperative nausea and vomiting (PONV) grade

  At 0, 2, 6, and 12 hours postoperatively

• Cumulative analgesic consumption (pethidine + tramadol)

  Within 24 hours postoperatively

• Rescue antiemetic requirement

  Within 24 hours postoperatively

• Early mobilization status

  At 2 hours postoperatively

Study Arms (2)

Paragastric Block with Bupivacaine

EXPERIMENTAL

Participants in this group will undergo laparoscopic sleeve gastrectomy with intraoperative paragastric block. A total of 20 mL of 0.5% bupivacaine will be injected into six predefined anatomical sites around the stomach under direct laparoscopic visualization after gastric resection. The block targets autonomic nerve plexuses to reduce postoperative visceral pain and nausea. The injection will be performed using a standardized technique with a 25G needle.

Drug: Bupivacaine 0.5%

Sham Block with Isotonic Saline

PLACEBO COMPARATOR

Participants in this group will undergo laparoscopic sleeve gastrectomy with a sham paragastric block. A total of 20 mL of isotonic saline will be injected into the same six anatomical sites using the same technique, timing, needle type, and volume as the intervention group, ensuring proper blinding. No active local anesthetic will be used.

Drug: Isotonic Saline (0.9% NaCl)

Interventions

Isotonic Saline (0.9% NaCl) DRUG

Participants receive 20 mL of isotonic saline (placebo) administered intraoperatively using the same injection technique and anatomical landmarks as the active treatment group, to maintain blinding.

Sham Block with Isotonic Saline

Bupivacaine 0.5% DRUG

Participants receive 20 mL of 0.5% bupivacaine administered intraoperatively as a paragastric block. The injection is performed under laparoscopic guidance at six predefined anatomical sites around the stomach following gastric resection.

Paragastric Block with Bupivacaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Istanbul Gedik University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Abdullah Sisik, MD, Professor of General Surgery

CONTACT

+905327252381; abdullahsisik@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The surgical team, anesthesia providers, patients, data collectors, and outcome assessors will all remain blinded to group allocation. To preserve masking, both the intervention and placebo procedures will be performed identically in terms of injection site, volume, and technique. Group assignment will be concealed using sequentially numbered, opaque envelopes opened only after induction of anesthesia.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of General Surgery

Model Details: Eligible patients will be randomly assigned in a 1:1 ratio to one of two parallel groups: (1) intraoperative paragastric block with 0.5% bupivacaine or (2) sham block with isotonic saline. Each participant will receive only one type of intervention throughout the study. No crossover will occur between groups.

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start: October 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 20, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 01 October 2025- 01 December 2025

Locations

TU (1)