Intravenous Versus Perineural Ondansetron for Laparoscopic Sleeve Gastrectomy

NCT06810882 | Recruiting

• 1 other identifier: 36264PR1032/1/25
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ondansetron; Laparoscopic; Gastrectomy

Keywords

Ondansetron; Laparoscopic; Gastrectomy

Outcome Measures

Primary Outcomes (2)

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

  Any attack of vomiting will be recorded for all patients.

  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.

  1 hour after surgery.

Secondary Outcomes (6)

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

  24 hours after surgery.

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

  24 hours after surgery.

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

  24 hours after surgery.

• Time to first rescue opioid analgesic.

  24 hours after surgery.

• Total opioid dose in the first day after surgery.

  24 hours after surgery.

Study Arms (2)

Perineural ondansetron group

EXPERIMENTAL

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

Intravenous ondansetron group

ACTIVE COMPARATOR

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

Interventions

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.

Perineural ondansetron group

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.

Intravenous ondansetron group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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..

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbia Governorate, 31527, Egypt

RECRUITING

Central Study Contacts

Osama M Rehab, MD

CONTACT

01095210806; osamarehab@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesiology, surgical intensive care and pain medicine

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 6, 2025
• Study Start: February 16, 2025
• Primary Completion (Estimated): December 16, 2026
• Study Completion (Estimated): December 17, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After completion of the study.
• Access Criteria: The data will be available upon reasonable request from the corresponding author.

Locations

EG (1)