An interventional study of Perineural ondansetron and Intravenous ondansetron in Ondansetron, Laparoscopic and Gastrectomy, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by Tanta University · Not applicable, Interventional, and Prevention
This prospective randomized non-inferiority study will be conducted to compare the analgesic anti-emetic effects of intravenous ondansetron versus perineural ondansetron in patients undergoing laparoscopic sleeve gastrectomy.
Obesity and its associated disorders have significant implications for health, resulting in heightened productivity loss and reduced life expectancy while also negatively impacting the quality of life of patients. Surgical intervention is the most effective way to achieve sustainable weight loss in patients with obesity and to alleviate the associated comorbidities. Despite the current availability of minimally invasive bariatric surgical treatments, postoperative pain remains a significant issue. Vagal and sympathetic afferent signals originating from the gastrointestinal system stimulate the vomiting center, causing nausea and vomiting. Paragastric autonomic neural blockade (PANB) is a new method performed by injecting local anesthetic material into three to four separate points along the border between the lesser omentum and the stomach (from the esophagogastric junction to the distal antrum), the hepatoduodenal ligament, and the area covering the left gastric artery. This procedure aims to prevent visceral pain and symptoms of nausea and vomiting. Ondansetron is a serotonin receptor (5-HT3) antagonist used commonly to manage postoperative nausea and vomiting (PONV) through intravenous (IV) injection. It also has a local anesthetic effect and many studies used it as adjuvant in various regional anesthetic techniques. In this study, investigators will compare the combined antiemetic analgesic effects of IV and perineural (adjuvant to the local anesthetic bupivacaine in PANB) ondansetron. The investigators hypothesized that perineural administration of ondansetron will be non-inferior to the IV route regarding prophylaxis against PONV, and will provide superior postoperative analgesic effects by its local anesthetic enhancing action.
Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
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Exclusion Criteria:
Para-gastric autonomic neural blockade will be performed (after separation of the stomach and performing the methylene blue leak test) using 20 ml solution containing 18 ml bupivacaine 0.5% plus 2 ml (4 mg) ondansetron. At the same time, 15 ml saline will be injected slowly IV over 15 minutes.
Drug: Perineural ondansetron
Para-gastric autonomic neural blockade will be performed (after separation of the stomach and performing the methylene blue leak test) using 20 ml solution containing 18 ml bupivacaine 0.5% plus 2 ml saline. At the same time, 4 mg (2 ml) ondansetron mixed with 13 ml saline (total 15 ml) will be slowly injected IV over 15 minutes.
Drug: Intravenous ondansetron
Para-gastric autonomic neural blockade will be performed (after separation of the stomach and performing the methylene blue leak test) using 20 ml solution containing 18 ml bupivacaine 0.5% plus 2 ml (4 mg) ondansetron. At the same time, 15 ml saline will be injected slowly IV over 15 minutes.
Para-gastric autonomic neural blockade will be performed (after separation of the stomach and performing the methylene blue leak test) using 20 ml solution containing 18 ml bupivacaine 0.5% plus 2 ml saline. At the same time, 4 mg (2 ml) ondansetron mixed with 13 ml saline (total 15 ml) will be slowly injected IV over 15 minutes.
Incidence of vomiting in the early 8 hours after surgery.
Any attack of vomiting will be recorded for all patients.
Time frame: 8 hours after surgery.
Degree of postoperative pain at 1 hour after surgery as measured by the numerical rating scale pain score.
Numerical rating scale pain score (NRS) ranges from 0 = no pain to 10= worst pain.
Time frame: 1 hour after surgery.
Incidence of postoperative nausea and vomiting at 1 h, 8 h, and at 24 hours after surgery.
Any attack of nausea and vomiting will be recorded for all patients. Numerical rating scale from 0 (no nausea) to 10 (worst nausea) will be used to assess the severity of nausea.
Time frame: 24 hours after surgery.
Number of rescue anti-emetic doses in the first postoperative day.
Routine anti-emetics will be given every 8 hours in the form of IV metoclopramide 10 mg. Rescue anti-emetic medication in the form of ondansetron 8 mg slowly IV will be given. The total required dose and number of ondansetron boluses will be recorded.
Time frame: 24 hours after surgery.
Postoperative pain scores at 4 h, 8 h, and 24 hour after surgery.
Numerical rating scale pain score (NRS) ranges from 0 = no pain to 10= worst pain will be used to evaluate pain scores after surgery.
Time frame: 24 hours after surgery.
Time to first rescue opioid analgesic.
opioid dose will be given to patients with pain score ≥ 4.
Time frame: 24 hours after surgery.
Total opioid dose in the first day after surgery.
opioid dose will be given to patients with pain score ≥ 4.
Time frame: 24 hours after surgery.
Patient satisfaction
Likert-type scale of 0-5 points will assess satisfaction before discharge from the hospital .
Time frame: 24 hours after surgery.
Plan to share: Yes — The data will be available upon reasonable request from the corresponding author.
Supporting information: Study protocol, Sap
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Tanta University