Acue Postoperative PainPhase 1/2NCT07706348
Intraperitoneal Irrigation of Ondansteron in Combination With Lidocaine in Acute Postoperative Pain
A Phase 1/2 study testing ondansteron in people with Acue Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
This study, therefore, aimed to investigate the effect of intraperitoneal administration of ondansetron in combination to lidocaine for postoperative pain management in patients undergoing lower abdominal cancer surgery. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Acue Postoperative Pain
- What is being tested?
- ondansteron
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 1 Oct 2027
- Phase
- Phase 1/2
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II patients
- scheduled for major lower abdominal cancer surgeries.
Who cannot join
- patients with known allergy to the study drugs,
- significant cardiac, respiratory, renal or hepatic disease,
- body mass index (BMI) ≥30 kg/m2;
- allergy to study drugs
- history of opioid use for pain management the time of enrolment or drug addiction,
- who had used benzodiazepine chronically,
- stroke or psychiatric disease that could affect the perception of pain.
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
Assiut University - South Egypt Cancer Instiute
Asyut
About this study
Official title: Impact of Intraperitoneal Irrigation of Ondansteron in Combination With Lidocaine in Acute Postoperative Pain in Lower Abdominal Cancer Surgery: a Randomized Clinical Trial
This study, therefore, aimed to investigate the effect of intraperitoneal administration of ondansetron in combination to lidocaine for postoperative pain management in patients undergoing lower abdominal cancer surgery.
Read the detailed description
Postoperative pain relief is very important issue in any surgery. The common postoperative pain management is traditionally based on opioids (1,2). Considering opioids' adverse effects such as nausea, vomiting, sedation, drowsiness, and urinary retention, recently there is a lot of interest for f inding a safe and effective pain treatment after operation. Local anesthetics intraperitoneal instillation is recognized as a useful technique for postoperative pain management. They can reduce inflammatory response after surgery and produce analgesia by blocking neural transmission at the site of tissue injury (5). 5-HT3-antagonists, including ondansetron, are commonly used as anti-emetics to prevent and treat chemotherapy-induced vomiting and nausea [7]. Several studies have shown that 5-HT3-antagonists pose anti-inflammatory and analgesic properties, suggesting a potential clinical role in pain management.
- Conditions
- Acue Postoperative Pain
- Being tested
- ondansteron
- Keywords
- postoperative pain, ondasteron, intraperitoneal
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ondansteronDrug
intraperitonel irrigation
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron group (O group) | Active comparator | 8 mg ondansetron (4 mL) IP with 2% lidocain in dose 4mg/kg in total volume 30 ml instillation at the end of the procedure Receives: Drug: ondansteron |
| control group (C group) | Placebo comparator | lidocaune in dose 4mg/kg in total volume 30 ml with normal saline IP with lidocaine at the end of the procedure Receives: Drug: ondansteron |
What is being measured
The primary outcome is the main question the study is designed to answer.
total morphine consumption
total amount of morphine consumption in mg in the first 24 hours for analgesia
Measured: in the first 24 hours postoperative
Secondary outcomes (1)
time of the first request of analgesia
time between patients' extubation and first request of supplemental analgesia
Measured: first 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Jun 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acue Postoperative PainStudies of the same condition, open and under way.
- More trials run by Assiut 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intraperitoneal irregation
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Mamdouh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706348
- Sponsor's protocol ID
- 823
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intraperitoneal Irrigation of Ondansteron in Combination With Lidocaine in Acute Postoperative Pain in Lower Abdominal Cancer Surgery: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07706348
- Acronym / sponsor ID
- 823
- Conditions
- Acue Postoperative Pain
- Keywords
- postoperative pain, ondasteron, intraperitoneal
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 15 Jul 2026 (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 study, therefore, aimed to investigate the effect of intraperitoneal administration of ondansetron in combination to lidocaine for postoperative pain management in patients undergoing lower abdominal cancer surgery.
Detailed description
Postoperative pain relief is very important issue in any surgery. The common postoperative pain management is traditionally based on opioids (1,2). Considering opioids' adverse effects such as nausea, vomiting, sedation, drowsiness, and urinary retention, recently there is a lot of interest for f inding a safe and effective pain treatment after operation. Local anesthetics intraperitoneal instillation is recognized as a useful technique for postoperative pain management. They can reduce inflammatory response after surgery and produce analgesia by blocking neural transmission at the site of tissue injury (5). 5-HT3-antagonists, including ondansetron, are commonly used as anti-emetics to prevent and treat chemotherapy-induced vomiting and nausea [7]. Several studies have shown that 5-HT3-antagonists pose anti-inflammatory and analgesic properties, suggesting a potential clinical role in pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- intraperitoneal irregation
| Arm | Type | Receives |
|---|---|---|
| Ondansetron group (O group) | Active comparator | Drug: ondansteron8 mg ondansetron (4 mL) IP with 2% lidocain in dose 4mg/kg in total volume 30 ml instillation at the end of the procedure |
| control group (C group) | Placebo comparator | Drug: ondansteronlidocaune in dose 4mg/kg in total volume 30 ml with normal saline IP with lidocaine at the end of the procedure |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-II patients
- scheduled for major lower abdominal cancer surgeries.
Key exclusion criteria (7 listed)
- patients with known allergy to the study drugs,
- significant cardiac, respiratory, renal or hepatic disease,
- body mass index (BMI) ≥30 kg/m2;
- allergy to study drugs
- history of opioid use for pain management the time of enrolment or drug addiction,
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 |
|---|---|---|
| ondansteronintraperitonel irrigation | Drug | Ondansetron group (O group), control group (C group) |
Primary outcome
total morphine consumption
Time frame: in the first 24 hours postoperative
total amount of morphine consumption in mg in the first 24 hours for analgesia
1 secondary outcome
time of the first request of analgesia
Time frame: first 24 hours postoperative
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 Jul 2026.
- Individual participant dataSharing planned: Undecided
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 Phase 1/2 study testing ondansteron in people with Acue Postoperative Pain, run by Assiut 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 2 inclusion and 7 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 Jul 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 shereen mamdouh kamal, professor (+201006279209, drshereenmamdouh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total morphine consumption (time frame: in the first 24 hours postoperative). 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 Jul 2026.