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Prospective pharmacogenetic cohort study of CYP2D6 metabolizer phenotype, analgesic failure, and adverse effects in postoperative patients receiving tramadol by elastomeric infusion pump

NCT ID NCT07810816

NEW Sponsor: Research Inc Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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)
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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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

This prospective pharmacogenetic cohort will enroll postoperative patients receiving a standardized tramadol-containing elastomeric analgesia pump. CYP2D6 genotype will be measured but will not determine treatment during the 72-hour study window. Participants with non-normal metabolizer phenotypes will be compared with normal metabolizers for analgesic treatment failure and adverse effects. Pain, rescue medication, pump discontinuation, sedation, respiratory status, nausea/vomiting, and other adverse events will be assessed at prespecified times.

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Study facts

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

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Adults undergoing elective surgery who receive a standardized tramadol-containing elastomeric analgesia pump and consent to CYP2D6 genotyping.

Ages

18 years and older

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: * Elective surgery followed by the institution's standardized tramadol-containing elastomeric analgesia pump. * Ability to report pain on a 0-to-10 numeric rating scale. * Provision of a blood or buccal sample for CYP2D6 genotyping before or immediately after surgery. * Written informed consent for genetic testing, storage of genotype data, and clinical follow-up. Exclusion Criteria: * Known tramadol allergy or contraindication. * Chronic opioid therapy, opioid use disorder, or opioid tolerance requiring an individualized regimen. * Severe renal or hepatic dysfunction outside the standardized pump eligibility criteria. * Concomitant medication or condition that requires deviation from the standard pump before the first outcome assessment. * Pregnancy or breastfeeding. * Inability to provide reliable pain scores or complete 72-hour monitoring.

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Conditions

The condition(s) this trial relates to.

Drug-Related Side Effects and Adverse Reactions Pain, Postoperative

As listed by the trial registrant

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

Acute postoperative pain Pharmacogenetic variation Tramadol adverse effect

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Clinica Bioforma

    RECRUITING

    Medellín, Antioquia, Colombia

    Contact Email: •••••@•••••

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