Intravenous Versus Perineural Ondansetron for Laparoscopic Sleeve Gastrectomy

Tanta University

Status: Enrolling

Conditions: Laparoscopic; Gastrectomy; Ondansetron

Treatments: Drug: Intravenous ondansetron; Drug: Perineural ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT06810882

36264PR1032/1/25

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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..

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

170 participants in 2 patient groups

Perineural ondansetron group

Experimental group

Description:

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.

Treatment:

Drug: Perineural ondansetron

Intravenous ondansetron group

Active Comparator group

Description:

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.

Treatment:

Drug: Intravenous ondansetron