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CompletedNCT04468685Updated Jan 12, 2021

Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy

A Phase 2 interventional study of Ondansetron and Normal saline in Cholecystitis, sponsored by National Hepatology & Tropical Medicine Research Institute. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-01-12.

Sponsored by National Hepatology & Tropical Medicine Research Institute · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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. 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.

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Conditions studied

  • Cholecystitis

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03

In context

Cholecystitis

266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.

This study's enrollment of 50 is below the median of 86 across 167 interventional studies indexed under Cholecystitis.

Browse Cholecystitis studies →

Lead sponsor

National Hepatology & Tropical Medicine Research Institute is the lead sponsor of 19 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who are scheduled to undergo elective LC

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Ondansetron

    Ondansetron intraperitoneal in the gall bladder bed

    Drug: Ondansetron

  • Placebo comparator
    Saline

    Normal saline intraperitoneal in the gall bladder bed

    Drug: Normal saline

Interventions

  • DrugOndansetron

    Interperitoneal administration in the gall bladder bed

  • DrugNormal saline

    Interperitoneal administration in the gall bladder bed

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What researchers measure

Primary outcomes

  1. change in postoperative pain between the two groups using visual analogue score (VAS)

    Time frame: 24 hours

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Study locations

1 site
  • The National Hepatology and Tropical Research medicine institute
    Cairo, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04468685
Lead sponsor
National Hepatology & Tropical Medicine Research Institute
Responsible party
Doaa abdelaziz (Lecturer of clinical pharmacy, National Hepatology & Tropical Medicine Research Institute) — Principal investigator
First posted
Jul 13, 2020
Start date
Jul 15, 2020
Primary completion
Dec 18, 2020
Completion
Dec 18, 2020
Last update
Jan 12, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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