Comparing two methods of ondansetron administration for pain relief after weight loss surgery
Intravenous Versus Perineural Ondansetron as an Adjuvant in Autonomic Neural Blockade for Laparoscopic Sleeve Gastrectomy: A Two-Center, Randomized, Double-Blind, Non-inferiority Trial
This study is testing whether giving ondansetron through a nerve block can help reduce pain and nausea after weight loss surgery just as well as the traditional intravenous method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, Gharbia Governorate) |
| Trial ID | NCT06810882 on ClinicalTrials.gov |
What this trial studies
This prospective randomized non-inferiority study aims to evaluate the analgesic and anti-emetic effects of intravenous ondansetron versus perineural ondansetron in patients undergoing laparoscopic sleeve gastrectomy. The study focuses on addressing postoperative pain and nausea, which are common complications following bariatric surgery. By utilizing a novel approach called paragastric autonomic neural blockade, the researchers will assess the effectiveness of these two methods in managing symptoms post-surgery. The goal is to determine if perineural administration provides similar or superior benefits compared to the traditional intravenous route.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a BMI over 35 and associated comorbidities, scheduled for laparoscopic sleeve gastrectomy.
Not a fit: Patients with allergies to the study drugs, chronic pain disorders, or those with a history of gastrointestinal surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance postoperative care by reducing pain and nausea in patients undergoing weight loss surgery.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for effective pain and nausea management.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tanta, Gharbia Governorate
- Tanta University Hospitals — Tanta, Gharbia Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Osama M Rehab, MD
- Email: osamarehab@med.tanta.edu.eg
- Phone: 01095210806
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.