An observational study in Acute Postoperative Pain, Tramadol Adverse Effect and Pharmacogenetic Variation, sponsored by Research Inc. Recruiting at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Research Inc · Observational
Among 19 studies in Pain, Postoperative with a site in Colombia — 4 open to participants now, 4 under way, none of them phase 3. Pain, Postoperative · Colombia.
Among the 19 studies in Pain, Postoperative with a site in Colombia, this one is one of 2 that started in 2023, is one of 5 observational ones, and was the 18th registered.
5,644 studies on the registry are indexed under Pain, Postoperative; 1,229 are open to participants now.
Browse Pain, Postoperative studies →4 of the 19 studies in Pain, Postoperative with a site in Colombia are open now. Recruiting first, the newest first:
Universidad de Antioquia · Sites in Colombia
Ages 18+ · Healthy volunteers
Research Inc · Sites in Colombia
Ages 18–55
Fundación Santa Fe de Bogota · Sites in Colombia
Ages 18+ · Women only
A study can be open while its sites in Colombia have not opened yet or have stopped. Only those recruiting at a site in Colombia →
Of the 678 Pain, Postoperative studies recruiting now, 241 (36%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
19 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 is above the median of 102 across 683 observational studies indexed under Pain, Postoperative.
Median enrollment 76 across the 14 interventional studies, 200 across the 5 observational. Of the 13 that completed or were terminated, 0 (0%) have results posted.
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2 of 19 have an industry lead sponsor. The 10 most frequent:
Research Inc is the lead sponsor of 24 studies on the registry; 22 are open to participants now.
Research Inc has 2 studies filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
1 of the studies in Pain, Postoperative with a site in Colombia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07859956Fundación Santa Fe de BogotaPain After Scheduled Cesarean Delivery: Spinal Morphine With or Without Levobupivacaine Wound Infiltration | 2027-07-14 |
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Among the 19 studies in Pain, Postoperative with a site in Colombia, from their registry updates:
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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.
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.
Adults undergoing elective surgery who receive a standardized tramadol-containing elastomeric analgesia pump and consent to CYP2D6 genotyping.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants classified by the validated assay as poor or ultrarapid metabolizers. Phenotype-specific subgroups will be analyzed separately.
Drug: Standardized Tramadol Elastomeric Analgesia Pump · Genetic: CYP2D6 Genotyping and Metabolizer Phenotype Assignment
Participants classified as normal metabolizers by the prespecified genotype-to-phenotype translation algorithm.
Drug: Standardized Tramadol Elastomeric Analgesia Pump · Genetic: CYP2D6 Genotyping and Metabolizer Phenotype Assignment
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.
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.
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.
Time frame: 1 week
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.
Time frame: 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.
Time frame: 1 week
Plan to share: No — no contempled in the patient informed concent
Ran from Jan 2023 to primary completion in Sep 2026, 43 months.
Of 395 observational studies under Pain, Postoperative, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's 43 months is above that.
How these figures are worked out, and which studies are left out of them.
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