Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT06606067
Eligibility Criteria:
Inclusion Criteria:
* Men resident in Spain who are scheduled for open inguinal hernia repair (inpatient or outpatient procedures).
* Risk of post-surgical pain chronification \> 27% using the GENDOLCAT risk scale.
Exclusion Criteria:
* Age under 18 years
* Patients who in the recruiter's opinion have insufficient knowledge of Spanish to understand the trial
* Patients who are currently being treated with duloxetine
* Patents with known allergy to duloxetine
* Serious renal failure (creatinine clearance \>30 ml/min)
* Patients requiring reoperation because of surgical complications
* Transplanted patients
* History of coronary artery disease, including previous myocardial infarction, angina, percutaneous transluminal coronary angioplasty
* History of congestive heart failure
* Currently taking a monoamine oxidase inhibitor or other medication with substantial interaction with duloxetine
* Antidepressant use within 4 weeks of study start
* Treatment with inhibitors of cytochrome P450 mixed-function oxidase system (CYP1A2): fluvoxamine, ciprofloxacin or enoxacin
* Uncontrolled hypertension
* Bipolar disorder
* History of seizures
* Elevated intraocular pressure or risk of acute glaucoma
* Treatment with selective serotonin reuptake inhibitors (SSRIs)
* Treatment with serotonin and noradrenaline reuptake inhibitors (SNRIs)
* Treatment with tricyclic antidepressants
* Treatment with triptans
* Treatment with antipsychotic drugs
* Treatment with dopamine antagonists
* Treatment with oral anticoagulant agents
* Treatment with Hypericum perforatum
* Major depression disorder
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT06606067
Study Brief:
Protocol Section:
NCT06606067