PreventionNCT05317611
Intravenous Versus Intraperitoneal Instillation of Ondansetron for Decreasing Incidence of Nausea and Vomiting After Laparoscopic Gynecological Surgeries.
A study testing Intraperitoneal instillation of ondansetron and bupivacaine, Intravenous ondansetron and intraperitoneal instillation of bupivacaine and Intraperitoneal instillation of bupivacaine in people with Prevention, run by Zagazig University at 1 site in Egypt.
Trial summary
Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic surgeries. Read more about this study
- Who is it for?
- Ages 21 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prevention
- What is being tested?
- Intraperitoneal instillation of ondansetron and bupivacaine, Intravenous ondansetron and intraperitoneal instillation of bupivacaine and Intraperitoneal instillation of bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 26 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent from the patient.
- Age: 21-60 years old.
- female patients
- Physical status: ASA 1\& II.
- BMI = ≤ 35 kg/m2).
- Type of operation: elective laparoscopic gynecological surgeries.
Who cannot join
- Altered mental state.
- Patients with known history of allergy to the study drugs.
- hepatic, renal impairment or disease , cardiovascular, and respiratory diseases.
- Patients with chronic pain received NSAID or opioid during previous two weeks.
- Patients with history of PONV or motion sickness and patients received antiemetic therapy 24 h before the surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Versus Intraperitoneal Instillation of Ondansetron for Decreasing Incidence of Nausea and Vomiting After Laparoscopic Gynecological Surgeries: A Randomized Controlled Study
Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic surgeries.
Read the detailed description
Laparoscopic surgeries have many advantages e.g., decreasing postoperative pain, better cosmetic, rapid recovery, and better recovery but also, it has side effects e.g., pain, postoperative nausea and vomiting.
There are many risk factors that cause PONV either patient related factors or anesthesia related factors (opioids, inhalational anesthetics, Nitrous oxide and duration of anesthesia) and surgery related factors (intraabdominal, laparoscopic, postoperative pain).
Intraperitoneal instillation of drugs can be used for instillation of LA, opoids, ketamine and antiemetics to provide analgesia and manage side effects of laparoscopic surgery. The mechanism of action of ondansetron is inhibition of presynaptic 5-HT3 receptors that located in the peripheral nervous. Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic surgeries.
- Conditions
- Prevention
- Being tested
- Intraperitoneal instillation of ondansetron and bupivacaine, Intravenous ondansetron and intraperitoneal instillation of bupivacaine, Intraperitoneal instillation of bupivacaine
- Keywords
- ondansetron, intraperitoneal instillation, laparoscopic gynecological surgeries, postoperative nausea and vomiting
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraperitoneal instillation of ondansetron and bupivacaineDrug
Also called Intraperitoneal instillation of zofran and marcaine
The aim is to detect the effect of intraperitoneal instillation of ondansetron for prevention of postoperative nausea and vomiting
Intravenous ondansetron and intraperitoneal instillation of bupivacaineDrug
Also called Intravenous zofran and intraperitoneal instillation of marcaine
The aim is to detect effect of intravenous ondansetron for prevention of postoperative nausea and vomiting
Intraperitoneal instillation of bupivacaineDrug
Also called Intraperitoneal instillation of marcaine
The aim is to detect effect of intraperitoneal instillation of bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Intraperitoneal instillation of ondansetron and bupivacaine (group A) | Active comparator | Patients will receive intraperitoneal instillation of (100 mg) 40 ml of bupivacaine 0.25 % and (4 mg) 2 ml ondansetron through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA. Receives: Drug: Intraperitoneal instillation of ondansetron and bupivacaine |
| Intravenous ondansetron and intraperitoneal instillation of bupivacaine (group B) | Active comparator | Patient will receive intravenous (4 mg) 2 ml ondansetron and intraperitoneal instillation of (100 mg) 40 ml of bupivacaine 0.25 % through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA. Receives: Drug: Intravenous ondansetron and intraperitoneal instillation of bupivacaine |
| Intraperitoneal instillation of bupivacaine (group C) | Active comparator | patient will receive intraperitoneal instillation of (100 mg) 40 ml of bupivacaine 0.25 % through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA. Receives: Drug: Intraperitoneal instillation of bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure incidence of postoperative nausea and vomiting
The number of patient suffering from postoperative nausea and vomiting in each group
Measured: 24 hours postoperative
measure severity of postoperative nausea and vomiting
Simplified Postoperative Nausea and Vomiting Impact Scale (S-PNVIS)
- *Frequency of Nausea:*
- 0: None
- 1: Occasionally (1-2 times a day)
- 2: Frequently (3-4 times a day)
- 3: Constantly (more than 4 times a day)
- *Frequency of Vomiting:*
- 0: None
- 1: Once a day
- 2: 2-3 times a day
- 3: More than 3 times a day
- *Impact on Daily Activities:*
- 0: No impact
- 1: Mild impact (able to perform most activities)
- 2: Moderate impact (some activities limited)
- 3: Severe impact (most activities limited) #Scoring
- *Total Score:* Sum of scores from all 3 items.
- *Interpretation:* Higher total scores indicate a greater impact of nausea and vomiting on the patient recovery
Measured: 24 hours postoperative
Secondary outcomes (5)
measure total numbers of rescue antiemetic
patients will receive 10 mg intravenous metoclopramide as rescue antiemetic immediately
Measured: all over 24 hours postoperative.
Duration of hospital stay
time from PACU discharge till time to discharge home
Measured: 24 hours to 72 hours
postoperative pain by Numerical Rating Scale
10 cm line numbered from 0 to 10, patients instructed to circle the number that represents his/her pain intensity (0=no pain and 10=maximum pain)
Measured: 0 hour (basal) in PACU, 2, 4, 8, 12, 24 hours postoperative
total dose of rescue analgesia postoperative
total dose of diclofenac as rescue analgesia postoperative
Measured: 24 hours postoperative
Patient satisfaction
degree of satisfaction of the analgesia by using a 5-points Likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia)
Measured: 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 posted8 Apr 2022
- Study start1 Jul 2022
- Primary completion15 Jan 2025
- Study completion26 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreventionStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic gynecological surgeries.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dina Abdelhameed Elsadek Salem, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317611
- Sponsor's protocol ID
- 9286-23-2-2022
- Status last verified
- Jan 2025
- First submitted
- 30 Mar 2022
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Versus Intraperitoneal Instillation of Ondansetron for Decreasing Incidence of Nausea and Vomiting After Laparoscopic Gynecological Surgeries: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05317611
- Acronym / sponsor ID
- 9286-23-2-2022
- Conditions
- Prevention
- Keywords
- ondansetron, intraperitoneal instillation, laparoscopic gynecological surgeries, postoperative nausea and vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 26 Jan 2025 (actual)
- First posted
- 8 Apr 2022 (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.
Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic surgeries.
Detailed description
Laparoscopic surgeries have many advantages e.g., decreasing postoperative pain, better cosmetic, rapid recovery, and better recovery but also, it has side effects e.g., pain, postoperative nausea and vomiting.
There are many risk factors that cause PONV either patient related factors or anesthesia related factors (opioids, inhalational anesthetics, Nitrous oxide and duration of anesthesia) and surgery related factors (intraabdominal, laparoscopic, postoperative pain).
Intraperitoneal instillation of drugs can be used for instillation of LA, opoids, ketamine and antiemetics to provide analgesia and manage side effects of laparoscopic surgery. The mechanism of action of ondansetron is inhibition of presynaptic 5-HT3 receptors that located in the peripheral nervous. Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic gynecological surgeries.
| Arm | Type | Receives |
|---|---|---|
| Intraperitoneal instillation of ondansetron and bupivacaine (group A) | Active comparator | Drug: Intraperitoneal instillation of ondansetron and bupivacainePatients will receive intraperitoneal instillation of (100 mg) 40 ml of bupivacaine 0.25 % and (4 mg) 2 ml ondansetron through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA. |
| Intravenous ondansetron and intraperitoneal instillation of bupivacaine (group B) | Active comparator | Drug: Intravenous ondansetron and intraperitoneal instillation of bupivacainePatient will receive intravenous (4 mg) 2 ml ondansetron and intraperitoneal instillation of (100 mg) 40 ml of bupivacaine 0.25 % through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA. |
| Intraperitoneal instillation of bupivacaine (group C) | Active comparator | Drug: Intraperitoneal instillation of bupivacainepatient will receive intraperitoneal instillation of (100 mg) 40 ml of bupivacaine 0.25 % through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written informed consent from the patient.
- Age: 21-60 years old.
- female patients
- Physical status: ASA 1\& II.
- BMI = ≤ 35 kg/m2).
Key exclusion criteria (5 listed)
- Altered mental state.
- Patients with known history of allergy to the study drugs.
- hepatic, renal impairment or disease , cardiovascular, and respiratory diseases.
- Patients with chronic pain received NSAID or opioid during previous two weeks.
- Patients with history of PONV or motion sickness and patients received antiemetic therapy 24 h before the 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 |
|---|---|---|
| Intraperitoneal instillation of ondansetron and bupivacaineAlso: Intraperitoneal instillation of zofran and marcaineThe aim is to detect the effect of intraperitoneal instillation of ondansetron for prevention of postoperative nausea and vomiting | Drug | Intraperitoneal instillation of ondansetron and bupivacaine (group A) |
| Intravenous ondansetron and intraperitoneal instillation of bupivacaineAlso: Intravenous zofran and intraperitoneal instillation of marcaineThe aim is to detect effect of intravenous ondansetron for prevention of postoperative nausea and vomiting | Drug | Intravenous ondansetron and intraperitoneal instillation of bupivacaine (group B) |
| Intraperitoneal instillation of bupivacaineAlso: Intraperitoneal instillation of marcaineThe aim is to detect effect of intraperitoneal instillation of bupivacaine | Drug | Intraperitoneal instillation of bupivacaine (group C) |
Primary outcome
measure incidence of postoperative nausea and vomiting
Time frame: 24 hours postoperative
The number of patient suffering from postoperative nausea and vomiting in each group
measure severity of postoperative nausea and vomiting
Time frame: 24 hours postoperative
Simplified Postoperative Nausea and Vomiting Impact Scale (S-PNVIS) 1. *Frequency of Nausea:* * 0: None * 1: Occasionally (1-2 times a day) * 2: Frequently (3-4 times a day) * 3: Constantly (more than 4 times a day) 2. *Frequency of Vomiting:* * 0: None * 1: Once a day * 2: 2-3 times a day * 3: More than 3 times a day 3. *Impact on Daily Activities:* * 0: No impact * 1: Mild impact (able to perform most activities) * 2: Moderate impact (some activities limited) * 3: Severe impact (most activities limited) #Scoring * *Total Score:* Sum of scores from all 3 items. * *Interpretation:* Higher total scores indicate a greater impact of nausea and vomiting on the patient recovery
5 secondary outcomes
measure total numbers of rescue antiemetic
Time frame: all over 24 hours postoperative.
Duration of hospital stay
Time frame: 24 hours to 72 hours
postoperative pain by Numerical Rating Scale
Time frame: 0 hour (basal) in PACU, 2, 4, 8, 12, 24 hours postoperative
total dose of rescue analgesia postoperative
Time frame: 24 hours postoperative
Patient satisfaction
Time frame: 24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraperitoneal instillation of ondansetron and bupivacaine, Intravenous ondansetron and intraperitoneal instillation of bupivacaine and Intraperitoneal instillation of bupivacaine in people with Prevention, run by Zagazig 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 4 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure incidence of postoperative nausea and vomiting (time frame: 24 hours postoperative). 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 4 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.