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Which pill works best for Post-Surgery pain?

NCT ID NCT07587645

Symptom relief Sponsor: ISSSTE Hospital Regional "Gral. Ignacio Zaragoza" Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested two different painkillers given before leg surgery to see which one better prevents pain afterward. 46 adults took either tapentadol or pregabalin for three days before their operation. Researchers measured pain levels and how much extra pain medicine was needed after surgery.

What this could mean

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

Active substance
tapentadol and pregabalin
What this could lead to
If one drug works better, it could offer a more effective way to manage pain after leg surgery.
What could go wrong
This is a small pilot study with only 46 people, so results may not apply to everyone. The drugs also have side effects like nausea or dizziness.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

46 people

The number who actually took part.

Started

Jun 2024

Finished

Jul 2024

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 50 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: * Age 18-50 years * ASA physical status I or II * Body mass index between 18 and 35 kg/m² * Scheduled for elective lower limb surgery under neuraxial anaesthesia * Willing to provide written informed consent Exclusion Criteria: * Chronic use of analgesics or gabapentinoids * Known hypersensitivity to tapentadol or pregabalin * Pre-existing chronic pain Elimination Criteria: * Hypersensitivity reaction to any study drug during administration * Hemodynamic shock of any etiology * Requirement for advanced airway management or postoperative mechanical ventilation * Surgical duration exceeding 120 minutes * Requirement of an epidural catheter dose within the first two postoperative hours * Voluntary withdrawal of consent at any point

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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.

Acute postoperative pain Lower limb surgery

Contacts and locations

Locations

  • Hospital Regional "General Ignacio Zaragoza," ISSSTE

    Mexico City, Mexico City, 09360, Mexico

More trials for these conditions

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