OndansetronNCT06810882
Intravenous Versus Perineural Ondansetron for Laparoscopic Sleeve Gastrectomy
A study testing Perineural ondansetron and Intravenous ondansetron in people with Ondansetron and Laparoscopic, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ondansetron, Laparoscopic, Gastrectomy
- What is being tested?
- Perineural ondansetron and Intravenous ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 482 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Feb 2025to 17 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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..
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta, Gharbia Governorate, 31527
Osama M Rehab, MD, 01095210806, osamarehab@med.tanta.edu.eg
Osama M Rehab, MD
About this study
Official 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
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.
Read the detailed 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.
- Conditions
- Ondansetron, Laparoscopic, Gastrectomy
- Being tested
- Perineural ondansetron, Intravenous ondansetron
- Keywords
- Ondansetron, Laparoscopic, Gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineural ondansetronDrug
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 ondansetronDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Intravenous ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of vomiting in the early 8 hours after surgery.
Any attack of vomiting will be recorded for all patients.
Measured: 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.
Measured: 1 hour after surgery.
Secondary outcomes (6)
Incidence of postoperative nausea and vomiting at 1 h, 8 h, and at 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.
Measured: 24 hours after surgery.
Number of rescue anti-emetic doses in the first postoperative day.
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.
Measured: 24 hours after surgery.
Postoperative pain scores at 4 h, 8 h, and 24 hour 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.
Measured: 24 hours after surgery.
Time to first rescue opioid analgesic.
opioid dose will be given to patients with pain score ≥ 4.
Measured: 24 hours after surgery.
Total opioid dose in the first day after surgery.
opioid dose will be given to patients with pain score ≥ 4.
Measured: 24 hours after surgery.
Patient satisfaction
Likert-type scale of 0-5 points will assess satisfaction before discharge from the hospital .
Measured: 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start16 Feb 2025
- Primary completion16 Feb 2027 (estimated)
- Study completion17 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OndansetronStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 482 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Rehab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810882
- Sponsor's protocol ID
- 36264PR1032/1/25
- Status last verified
- May 2026
- First submitted
- 27 Jan 2025
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06810882
- Acronym / sponsor ID
- 36264PR1032/1/25
- Conditions
- Ondansetron, Laparoscopic, Gastrectomy
- Keywords
- Ondansetron, Laparoscopic, Gastrectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 482 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 16 Feb 2025 (actual)
- Primary completion
- 16 Feb 2027 (estimated)
- Study completion
- 17 Feb 2027 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perineural ondansetron group | Experimental | Drug: Perineural ondansetronPara-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 group | Active comparator | Drug: Intravenous ondansetronPara-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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..
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineural ondansetronPara-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 group |
| Intravenous ondansetronPara-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 group |
Primary outcome
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.
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.
6 secondary outcomes
Incidence of postoperative nausea and vomiting at 1 h, 8 h, and at 24 hours after surgery.
Time frame: 24 hours after surgery.
Number of rescue anti-emetic doses in the first postoperative day.
Time frame: 24 hours after surgery.
Postoperative pain scores at 4 h, 8 h, and 24 hour after surgery.
Time frame: 24 hours after surgery.
Time to first rescue opioid analgesic.
Time frame: 24 hours after surgery.
Total opioid dose in the first day after surgery.
Time frame: 24 hours after surgery.
Patient satisfaction
Time frame: 24 hours after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineural ondansetron and Intravenous ondansetron in people with Ondansetron and Laparoscopic, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osama M Rehab, MD (01095210806, osamarehab@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of vomiting in the early 8 hours after surgery. (time frame: 8 hours after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.