Intravenous Versus Perineural Ondansetron for Laparoscopic Sleeve Gastrectomy

Официальное название

Intravenous Versus Perineural Ondansetron as an Adjuvant in Autonomic Neural Blockade for Laparoscopic Sleeve Gastrectomy: A Two-Center, Randomized, Double-Blind, Non-inferiority Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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 (4 mg) ondansetron. At the same time, 15 ml saline will be injected slowly IV over 15 minutes.
• Препарат 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 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.

Первичные конечные точки

• Incidence of vomiting in the early 8 hours after surgery. [Срок оценки: 8 hours after surgery.]
• Degree of postoperative pain at 1 hour after surgery as measured by the numerical rating scale pain score. [Срок оценки: 1 hour after surgery.]

Вторичные конечные точки (6)

• Incidence of postoperative nausea and vomiting at 1 h, 8 h, and at 24 hours after surgery. [Срок оценки: 24 hours after surgery.]
• Number of rescue anti-emetic doses in the first postoperative day. [Срок оценки: 24 hours after surgery.]
• Postoperative pain scores at 4 h, 8 h, and 24 hour after surgery. [Срок оценки: 24 hours after surgery.]
• Time to first rescue opioid analgesic. [Срок оценки: 24 hours after surgery.]
• Total opioid dose in the first day after surgery. [Срок оценки: 24 hours after surgery.]
• Patient satisfaction [Срок оценки: 24 hours after surgery.]

Критерии участия

Критерии включения

• Patients of either sex
• American Society Anesthesiologists physical (ASA) status II-III
• age between 18-65 years old
• Body mass index (BMI) >35 kg/m2 with comorbidity or > 40 kg/m2 -- undergoing laparoscopic sleeve gastrectomy with intraoperative surgeon performed laparoscopic paragastric autonomic neural blockade..

Критерии исключения

• Allergy to experimental drugs.
• Known to have long QT, previous history of postoperative nausea and vomiting
• Abuse of alcohol, analgesia, or sedative antidepressant drugs
• Chronic pain disorders
• History of previous upper gastrointestinal system surgery, those with surgery-related complications during or after surgery.
• Liver or kidney failure
• Performance of concomitant procedures in addition to laparoscopic sleeve gastrectomy
• Anesthetic complications that may alter the postoperative management protocol.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Египет · 1 центр

• Tanta University Hospitals — Tanta

Идентификаторы

NCT: NCT06810882 · 36264PR1032/1/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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