Impact of Intraoperative Paragastric Block on Visceral Pain and Postoperative Nausea and Vomiting After Sleeve Gastrectomy: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Adults aged 18 to 65 years Scheduled for elective laparoscopic sleeve gastrectomy American Society of Anesthesiologists (ASA) physical status I-III Ability to provide written informed consent Willingness to comply with all study procedures

Locations
Other Locations
Turkey
Istanbul Gedik University
RECRUITING
Istanbul
Contact Information
Primary
Abdullah Sisik, MD, Professor of General Surgery
abdullahsisik@gmail.com
+905327252381
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2026-01-20
Participants
Target number of participants: 200
Treatments
Experimental: Paragastric Block with Bupivacaine
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.
Placebo_comparator: Sham Block with Isotonic Saline
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.
Sponsors
Leads: Umraniye Education and Research Hospital

This content was sourced from clinicaltrials.gov