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NCT Number: NCT06810882

Intravenous Versus Perineural Ondansetron for Laparoscopic Sleeve Gastrectomy

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.

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Key information

Conditions

Ondansetron Gastrectomy Laparoscopic

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, Gharbia Governorate, 31527, Egypt

Location status: Recruiting

Location contact

Doha M Bakr, MD

SUB_INVESTIGATOR

Osama M Rehab, MD

CONTACT

[email protected]

01095210806

Osama M Rehab, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Perineural ondansetron

Drug

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.

Intravenous ondansetron

Drug

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.

Primary outcomes

  1. Incidence of vomiting in the early 8 hours after surgery.

    Time frame: 8 hours after surgery.

    Any attack of vomiting will be recorded for all patients.

  2. Degree of postoperative pain at 1 hour after surgery as measured by the numerical rating scale pain score.

    Time frame: 1 hour after surgery.

    Numerical rating scale pain score (NRS) ranges from 0 = no pain to 10= worst pain.

Secondary outcomes

  1. Incidence of postoperative nausea and vomiting at 1 h, 8 h, and at 24 hours after surgery.

    Time frame: 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.

  2. Number of rescue anti-emetic doses in the first postoperative day.

    Time frame: 24 hours after surgery.

    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.

  3. Postoperative pain scores at 4 h, 8 h, and 24 hour after surgery.

    Time frame: 24 hours 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.

  4. Time to first rescue opioid analgesic.

    Time frame: 24 hours after surgery.

    opioid dose will be given to patients with pain score ≥ 4.

  5. Total opioid dose in the first day after surgery.

    Time frame: 24 hours after surgery.

    opioid dose will be given to patients with pain score ≥ 4.

  6. Patient satisfaction

    Time frame: 24 hours after surgery.

    Likert-type scale of 0-5 points will assess satisfaction before discharge from the hospital .

Study contacts

Contact information is provided by the study sponsor or research team.

Osama M Rehab, MD

CONTACT

[email protected]

01095210806

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2025
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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