Acute Postoperative PainNCT07810816
Prospective Pharmacogenetic Cohort Study of CYP2D6 Metabolizer Phenotype, Analgesic Failure, and Adverse Effects in Postoperative Patients Receiving Tramadol by Elastomeric Infusion Pump
An observational study of Acute Postoperative Pain and Tramadol Adverse Effect, run by Research Inc at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Postoperative Pain, Tramadol Adverse Effect, Pharmacogenetic Variation
- What is being tested?
- Standardized Tramadol Elastomeric Analgesia Pump and CYP2D6 Genotyping and Metabolizer Phenotype Assignment
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteColombia
- Study dates
- 12 Jan 2023to 1 Dec 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing elective surgery who receive a standardized tramadol-containing elastomeric analgesia pump and consent to CYP2D6 genotyping.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Clinica Bioforma
Medellín, Antioquia
Edison Osorio, MD, Plastic surgeon, +573226140611, info@edisonosorio.com
About this study
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.
Read the detailed description
All participants will receive the same institutional tramadol pump regimen as routine postoperative care. A preoperative or immediate postoperative sample will undergo CYP2D6 genotyping, including copy-number assessment under the validated laboratory method. Pain and adverse effects will be recorded repeatedly through 72 hours while clinical care remains unrestricted. The primary analysis compares any non-normal phenotype with normal metabolizers, as proposed by the investigator. Because reduced- and increased-function phenotypes may affect different outcomes, separate poor/intermediate and rapid/ultrarapid analyses are prespecified. Models will account for CYP2D6 inhibitors, organ function, surgical procedure, anesthesia, and concomitant analgesia.
- Being tested
- Standardized Tramadol Elastomeric Analgesia Pump, CYP2D6 Genotyping and Metabolizer Phenotype Assignment
- Keywords
- CYP2D6, Tramadol, Pharmacogenetics, Analgesic Failure, Adverse Drug Reaction, Postoperative Pain
- Medical subject headings
- Pain, Postoperative, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Tramadol Elastomeric Analgesia PumpDrug
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 AssignmentGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-Normal CYP2D6 Phenotype | Participants classified by the validated assay as poor or ultrarapid metabolizers. Phenotype-specific subgroups will be analyzed separately. Receives: Drug: Standardized Tramadol Elastomeric Analgesia Pump; Genetic: CYP2D6 Genotyping and Metabolizer Phenotype Assignment | |
| Normal CYP2D6 Metabolizer | Participants classified as normal metabolizers by the prespecified genotype-to-phenotype translation algorithm. Receives: Drug: Standardized Tramadol Elastomeric Analgesia Pump; Genetic: CYP2D6 Genotyping and Metabolizer Phenotype Assignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Analgesic Treatment Failure
Proportion of participants with at least one prespecified failure criterion: pain score 4 or higher at two consecutive scheduled assessments despite protocol-allowed adjustment, rescue opioid above the locked threshold, premature pump discontinuation for inadequate analgesia, or replacement by another analgesic technique.
Measured: 1 week
Secondary outcomes (2)
Incidence of Tramadol-Related Adverse Effects
Proportion with treated nausea/vomiting, excessive sedation, respiratory depression, dizziness, pruritus, confusion, hallucinations, or another event adjudicated as probably or definitely related to tramadol.
Measured: 1 week
Phenotype-Specific Composite Outcome
Separate estimates for poor/intermediate, normal, and rapid/ultrarapid metabolizers for analgesic failure and adverse-effect outcomes; these analyses address the expected opposite directions of reduced and increased CYP2D6 activity.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start12 Jan 2023
- Primary completion1 Sep 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edison Osorio, MD, plastic surgery, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810816
- Sponsor's protocol ID
- 025
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no contempled in the patient informed concent
Publications
Ruano G, Kost JA. Fundamental Considerations for Genetically-Guided Pain Management with Opioids Based on CYP2D6 and OPRM1 Polymorphisms. Pain Physician. 2018 Nov;21(6):E611-E621.
PubMed 30508992Zahari Z, Ismail R. Influence of Cytochrome P450, Family 2, Subfamily D, Polypeptide 6 (CYP2D6) polymorphisms on pain sensitivity and clinical response to weak opioid analgesics. Drug Metab Pharmacokinet. 2014;29(1):29-43. doi: 10.2133/dmpk.dmpk-13-rv-032. Epub 2013 Jun 11.
PubMed 23759977Gan SH, Ismail R, Wan Adnan WA, Zulmi W. Impact of CYP2D6 genetic polymorphism on tramadol pharmacokinetics and pharmacodynamics. Mol Diagn Ther. 2007;11(3):171-81. doi: 10.1007/BF03256239.
PubMed 17570739Cavallari LH, Myers RA, Chakraborty H, Skaar TC, Gray CF, Baye JF, Volpi S, Rider R, Cicali EJ, Elwood EN, Harris EC, Hines LJ, Nahid NA, Nguyen KA, Obeng AO, Parr JA, Ramos MA, Orlando LA, Prieto HA, Sadeghpour A, Singh R, Starostik P, Tillman EM, Wyatt C, Horowitz CR, Voora D, Blake KV, Parvataneni HK, Fillingim RB, Dexter PR, Peterson JF, Johnson JA; IGNITE Pragmatic Trials Network. CYP2D6-Guided Opioid Management and Postoperative Pain Control: A Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2558299. doi: 10.1001/jamanetworkopen.2025.58299.
PubMed 41719044Mahajna M, Abu Fanne R, Odeh M, Berkovitch M, Tannous E, Eyal S, Vinker S, Green I, Matok I. Influence of cytochrome P450 2D6*10/*10 genotype on the risk for tramadol associated adverse effects: a retrospective cohort study. Front Pharmacol. 2024 Feb 19;15:1358549. doi: 10.3389/fphar.2024.1358549. eCollection 2024.
PubMed 38440181Percevault S, De La Gastine B, Varin L, Richard N, Fobe F, Plaud B, Daccache G, Compere V, Parienti JJ, Coquerel A, Loilier M, Bleyzac N, Bourguignon L, Lelong-Boulouard V, Goutelle S. Influence of CYP2D6 phenotype on the pharmacokinetics and pharmacodynamics of tramadol in patients treated for post-operative pain management. Anaesth Crit Care Pain Med. 2026 May;45(3):101781. doi: 10.1016/j.accpm.2026.101781. Epub 2026 Mar 4.
PubMed 41791456