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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
Sponsor: Research Inc
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2023-01-12
Completion Date
2026-12-01
Last Updated
2026-09-09
Healthy Volunteers
No
Interventions
Standardized Tramadol Elastomeric Analgesia Pump
All participants receive the same institutionally approved tramadol-based pump formulation, basal rate, duration, and allowed co-analgesics as routine care. Exact concentration, total dose, infusion rate, rescue regimen, and stopping criteria must be inserted in the final protocol. Linked arm/group(s): Non-Normal CYP2D6 Phenotype, Normal CYP2D6 Metabolizer.
CYP2D6 Genotyping and Metabolizer Phenotype Assignment
A validated clinical assay will detect prespecified CYP2D6 alleles and copy-number variation. Genotypes will be translated to activity score and metabolizer phenotype using a locked laboratory algorithm. Results will remain unavailable to the care team during the 72-hour observational window unless the ethics-approved safety plan requires disclosure. Linked arm/group(s): Non-Normal CYP2D6 Phenotype, Normal CYP2D6 Metabolizer.
Locations (1)
Clinica Bioforma
Medellín, Antioquia, Colombia