Pharmacogenetics of Tramadol Pain Control in Postoperative Care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational cohort study in postoperative patients who receive a standardized tramadol elastomeric infusion pump. Participants will have their CYP2D6 genotype determined pre- or immediately post-surgery, but treatment will not be altered during the 72-hour monitoring period. The main comparison is between non-normal metabolizers and normal metabolizers to see if analgesic failure or adverse effects differ, with prespecified analyses for poor/intermediate versus rapid/ultrarapid phenotypes. Data on pain scores, need for rescue medication, pump discontinuation, sedation, respiratory status, nausea/vomiting, and other adverse events will be collected at predefined times, while routine clinical care continues. The analysis will adjust for inhibitors, organ function, surgical procedure, anesthesia, and other analgesics to isolate the potential impact of CYP2D6 phenotype on outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinica Bioforma
  Medellín, Antioquia, Colombia Recruiting

Study contacts

• Principal investigator: Edison Osorio, MD, plastic surgery
• Study coordinator: Edison Osorio, MD, Plastic surgeon
• Email: info@edisonosorio.com
• Phone: +573226140611

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.