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Antidepressant may double as pain reliever after gallbladder surgery

NCT ID NCT06561438

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are studying whether a single dose of vortioxetine, an antidepressant, can reduce pain after laparoscopic gallbladder removal. The trial enrolls 86 adults scheduled for this common surgery. Participants receive either vortioxetine or a placebo two hours before the operation. The team measures pain intensity and how long until patients ask for additional pain relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vortioxetine, an antidepressant drug
What this could lead to
If it works, vortioxetine could become a new option for managing pain after gallbladder surgery, possibly reducing reliance on standard painkillers.
What could go wrong
This is a single Phase 3 trial with 86 patients, so results may not apply to everyone. Vortioxetine can cause side effects like nausea, dizziness, and sleep problems, and it may not relieve pain better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

86 people

The number who actually took part.

Started

Aug 2024

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients who are scheduled to undergo elective LC. * Adults (males and/or females) between the ages of 18-70 years old. Exclusion Criteria: * 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 vortioxetine. * Pregnancy and lactation * Patients with communication problems, cognitive dysfunction, or psychological disorders * Daily corticosteroid use

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Conditions

The condition(s) this trial relates to.

Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • National Hepatology and Tropical Research Institute

    Cairo, 11617, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.