Post Operative PainPhase 3NCT06281418
Postoperative Intraperitoneal Pain Management Following Laparoscopic Cholecystectomy
A Phase 3 study testing Granisetron 1 Mg/mL Intravenous Solution and Normal saline in people with Post Operative Pain, run by Future University in Egypt at 1 site in Egypt.
Trial summary
Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. No. study has investigated IP granisetron as an adjuvant to standard care for postoperative pain management in patients undergoing LC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Granisetron 1 Mg/mL Intravenous Solution and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Feb 2024to 4 Dec 2024
- Phase
- Phase 3
- 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.
- Adults (males and/or females) between the ages of 18-70 years old.
Who cannot join
- Chronic pain other than cholelithiasis.
- Patients who received analgesics or sedatives 24 h before scheduled surgery.
- Severe hepatic (Child Pugh Class B and C) and renal dysfunction (CrCl <30ml/min)
- Previous allergic response to granisetron.
- Pregnancy and lactation
- Patients with communication problems, cognitive dysfunction, or psychological disorders
- Daily corticosteroid use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain Management Following Laparoscopic Cholecystectomy- Intraperitoneal Granisetron
Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. No. study has investigated IP granisetron as an adjuvant to standard care for postoperative pain management in patients undergoing LC.
Read the detailed description
Postoperative pain is a main challenge for delayed hospital discharge in Laparoscopic cholecystectomy. . Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. Granisetron is frequently used as a premedication to avoid postoperative nausea and vomiting in patients who have undergone general anesthesia. The purpose of this study is evaluating the efficacy and tolerability of IP granisetron on postoperative pain control in patients undergoing LC
- Conditions
- Post Operative Pain
- Being tested
- Granisetron 1 Mg/mL Intravenous Solution, Normal saline
- Keywords
- laparoscopic, post-operative pain, serotonin 5HT3 receptor antagonist
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granisetron 1 Mg/mL Intravenous SolutionDrug
2mL intraperitoneal adminstration of granisetron (1 mg/mL)
Normal salineOther
2 ml IP normal saline (0.9% NaCl)
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Placebo comparator | 2 ml IP normal saline (0.9 % NaCl) Receives: Other: Normal saline |
| Intervention arm | Experimental | 2ml IP granisetron (1 mg/mL) Receives: Drug: Granisetron 1 Mg/mL Intravenous Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
Pain intensity: VAS score
Measured: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours
Secondary outcomes (2)
Time to analgesic request
Time to first rescue analgesic request
Measured: 24 hours
Quality of life (QoL) after laparoscopic cholecystectomy (LC)
Gastrointestinal Quality of Life Index questionnaire for QOL assessment with calculation of the score; most desirable option: 4 points, least desirable option: 0 points and GIQLI score: sum of the point. GIQLI ranges from 0 to 80 with higher scores indicating a better quality of life.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start29 Feb 2024
- Primary completion4 Dec 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoda Mohamed, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281418
- Sponsor's protocol ID
- 5-24
- Status last verified
- Jan 2025
- First submitted
- 18 Feb 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bayoumi HM, Abdelaziz DH, Boraii S, Bendas ER, El Said NO. Intraperitoneal Granisetron for Post-Laparoscopic Cholecystectomy Pain Management: A Double-Blinded, Randomized Controlled Trial. Pharmacotherapy. 2025 Sep;45(9):547-556. doi: 10.1002/phar.70046. Epub 2025 Jul 23.
PubMed 40698525
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Management Following Laparoscopic Cholecystectomy- Intraperitoneal Granisetron
- ClinicalTrials.gov ID
- NCT06281418
- Acronym / sponsor ID
- 5-24
- Conditions
- Post Operative Pain
- Keywords
- laparoscopic, post-operative pain, serotonin 5HT3 receptor antagonist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 28 Feb 2024 (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.
Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. No. study has investigated IP granisetron as an adjuvant to standard care for postoperative pain management in patients undergoing LC.
Detailed description
Postoperative pain is a main challenge for delayed hospital discharge in Laparoscopic cholecystectomy. . Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. Granisetron is frequently used as a premedication to avoid postoperative nausea and vomiting in patients who have undergone general anesthesia. The purpose of this study is evaluating the efficacy and tolerability of IP granisetron on postoperative pain control in patients undergoing LC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Placebo comparator | Other: Normal saline2 ml IP normal saline (0.9 % NaCl) |
| Intervention arm | Experimental | Drug: Granisetron 1 Mg/mL Intravenous Solution2ml IP granisetron (1 mg/mL) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are scheduled to undergo elective LC.
- Adults (males and/or females) between the ages of 18-70 years old.
Key exclusion criteria (7 listed)
- Chronic pain other than cholelithiasis.
- Patients who received analgesics or sedatives 24 h before scheduled surgery.
- Severe hepatic (Child Pugh Class B and C) and renal dysfunction (CrCl <30ml/min)
- Previous allergic response to granisetron.
- Pregnancy and lactation
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 |
|---|---|---|
| Granisetron 1 Mg/mL Intravenous Solution2mL intraperitoneal adminstration of granisetron (1 mg/mL) | Drug | Intervention arm |
| Normal saline2 ml IP normal saline (0.9% NaCl) | Other | Control arm |
Primary outcome
VAS score
Time frame: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours
Pain intensity: VAS score
2 secondary outcomes
Time to analgesic request
Time frame: 24 hours
Quality of life (QoL) after laparoscopic cholecystectomy (LC)
Time frame: 3 months
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 10 Jan 2025.
- Derived from this study: PubMed 40698525Bayoumi HM, Abdelaziz DH, Boraii S, Bendas ER, El Said NO. Intraperitoneal Granisetron for Post-Laparoscopic Cholecystectomy Pain Management: A Double-Blinded, Randomized Controlled Trial. Pharmacotherapy. 2025 Sep;45(9):547-556. doi: 10.1002/phar.70046. Epub 2025 Jul 23.
- 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 3 study testing Granisetron 1 Mg/mL Intravenous Solution and Normal saline in people with Post Operative Pain, run by Future University in Egypt 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: finished, as of the sponsor's last update on 10 Jan 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
VAS score (time frame: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06281418, which also lists 1 linked publication.
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 10 Jan 2025.