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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

Recruitingn/aAges 18 Years - anyAllResearch Inc
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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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What it tests

  • Standardized Tramadol Elastomeric Analgesia Pump
  • CYP2D6 Genotyping and Metabolizer Phenotype Assignment
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Where

1 site
Clinica Bioforma
Medellín, Colombia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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