Paragastric Block for Pain and PONV in Sleeve Gastrectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUmraniye Education and Research Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Bupivacaine 0.5%
DrugParticipants 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.
Isotonic Saline (0.9% NaCl)
DrugParticipants 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Paragastric Block with BupivacaineExperimental treatment 1 intervention
Group B: Sham Block with Isotonic SalinePlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
At 0 and 2 hours postoperativelySecondary outcomes
1
Postoperative nausea and vomiting (PONV) grade
PONV will be evaluated using a standardized 4-point grading scale: Grade 0 (no nausea/vomiting), Grade 1 (nausea only), Grade 2 (nausea with \<3 vomiting episodes/day), Grade 3 (≥3 vomiting episodes/day).
Time frame
At 0, 2, 6, and 12 hours postoperatively2
Cumulative analgesic consumption (pethidine + tramadol)
Total dose of rescue analgesics (pethidine and tramadol) administered during the first 24 hours after surgery will be recorded in milligrams for each patient.
Time frame
Within 24 hours postoperatively3
Rescue antiemetic requirement
Use of rescue antiemetic medication (metoclopramide 10 mg IV) will be recorded if postoperative nausea or vomiting occurs despite prophylactic ondansetron.
Time frame
Within 24 hours postoperatively4
Early mobilization status
Patient mobilization (defined as sitting upright or ambulating) will be assessed at 2 hours postoperatively and documented as "mobilized" or "not mobilized."
Time frame
At 2 hours postoperativelySponsors and contacts
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Umraniye Education and Research Hospital
Lead sponsor
Istanbul Gedik University
Sponsor institution
Source ClinicalTrials.gov