CholecystitisPhase 2NCT04468685
Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy
A Phase 2 study testing Ondansetron and Normal saline in people with Cholecystitis, run by National Hepatology & Tropical Medicine Research Institute at 1 site in Egypt.
Trial summary
Laparoscopic cholecystectomy (LC) is an easy procedure characterized by its minimal invasiveness, less post-operative pain and early recovery when compared to the open conventional cholecystectomy. However, patients who have undergone LC still complain of postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cholecystitis
- What is being tested?
- Ondansetron and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2020to 18 Dec 2020
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are scheduled to undergo elective LC
Who cannot join
- Patients undergoing chronic pain treatment
- Previous allergic response to local anesthetics or 5-HT3 receptor antagonists
- Patients who received analgesics or sedatives 24 h before scheduled surgery
Trial locations and contacts
1 site in 1 country.
Egypt1 site
The National Hepatology and Tropical Research medicine institute
Cairo
About this study
Official title: Efficacy of Intraperitoneal Ondansetron Administration on Pain Relief After Laparoscopic Cholecystectomy
Laparoscopic cholecystectomy (LC) is an easy procedure characterized by its minimal invasiveness, less post-operative pain and early recovery when compared to the open conventional cholecystectomy. However, patients who have undergone LC still complain of postoperative pain. It has been reported that ondansetron produces numbness when injected under the skin and has local anesthetic effect that is 15 times more potent than lidocaine the most widely used local anesthetic and probably explains its antiemetic action. It possesses anti-inflammatory, anesthetic, and analgesic properties by its multifaceted actions as a 5-HT3 receptor antagonist, a Na channel blocker, and a mu-opioid agonist which may have a potential role in decreasing pain. The study aimed to demonstrate the effectiveness of IP administration of ondansetron on pain management post LC.
- Conditions
- Cholecystitis
- Being tested
- Ondansetron, Normal saline
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Interperitoneal administration in the gall bladder bed
Normal salineDrug
Interperitoneal administration in the gall bladder bed
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Experimental | Ondansetron intraperitoneal in the gall bladder bed Receives: Drug: Ondansetron |
| Saline | Placebo comparator | Normal saline intraperitoneal in the gall bladder bed Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in postoperative pain between the two groups using visual analogue score (VAS)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start15 Jul 2020
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Hepatology & Tropical Medicine Research Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Doaa abdelaziz, National Hepatology & Tropical Medicine Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468685
- Sponsor's protocol ID
- 12-2020
- Status last verified
- Jan 2021
- First submitted
- 8 Jul 2020
- Last updated
- 12 Jan 2021
- 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 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intraperitoneal Ondansetron Administration on Pain Relief After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT04468685
- Acronym / sponsor ID
- 12-2020
- Conditions
- Cholecystitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Hepatology & Tropical Medicine Research InstituteOther government
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 13 Jul 2020 (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.
Laparoscopic cholecystectomy (LC) is an easy procedure characterized by its minimal invasiveness, less post-operative pain and early recovery when compared to the open conventional cholecystectomy. However, patients who have undergone LC still complain of postoperative pain. It has been reported that ondansetron produces numbness when injected under the skin and has local anesthetic effect that is 15 times more potent than lidocaine the most widely used local anesthetic and probably explains its antiemetic action. It possesses anti-inflammatory, anesthetic, and analgesic properties by its multifaceted actions as a 5-HT3 receptor antagonist, a Na channel blocker, and a mu-opioid agonist which may have a potential role in decreasing pain. The study aimed to demonstrate the effectiveness of IP administration of ondansetron on pain management post LC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron | Experimental | Drug: OndansetronOndansetron intraperitoneal in the gall bladder bed |
| Saline | Placebo comparator | Drug: Normal salineNormal saline intraperitoneal in the gall bladder bed |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are scheduled to undergo elective LC
Key exclusion criteria (3 listed)
- Patients undergoing chronic pain treatment
- Previous allergic response to local anesthetics or 5-HT3 receptor antagonists
- Patients who received analgesics or sedatives 24 h before scheduled 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 |
|---|---|---|
| OndansetronInterperitoneal administration in the gall bladder bed | Drug | Ondansetron |
| Normal salineInterperitoneal administration in the gall bladder bed | Drug | Saline |
Primary outcome
change in postoperative pain between the two groups using visual analogue score (VAS)
Time frame: 24 hours
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 12 Jan 2021.
- 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 Phase 2 study testing Ondansetron and Normal saline in people with Cholecystitis, run by National Hepatology & Tropical Medicine Research Institute 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 1 inclusion and 3 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 12 Jan 2021. 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 phase mean?
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?
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?
change in postoperative pain between the two groups using visual analogue score (VAS) (time frame: 24 hours). 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 12 Jan 2021.