Duloxetine to Prevent Chronic Postsurgical Pain After Inguinal Hernia Repair in Patients at High Risk
Active, not recruitingPhase 3NCT06606067
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The clinical trial will be conducted in 14 Spanish hospitals. It is estimated, based on our previous studies, that 2855 patients scheduled for elective inguinal hernia surgery will have to be assessed to detect patients with ≥ 27% level of risk for Chronic Post-Surgical Pain (CPSP). These high-risk patients will be randomized to 2 treatment groups: one will receive duloxetine for 2 weeks prior to surgery and 1 week after surgery (intervention group) and the other the placebo (control group) during the same periods. The primary outcome will be a ≥ 50% decrease in the CPSP incidence in the intervention group compared to the placebo group, 4 months after surgery.
Study details
- Official title
- Efficacy of Perioperative Duloxetine in Patients at High Risk for Developing Chronic Postsurgical Pain After Inguinal Hernia Repair: a Multicenter Randomized Controlled Trial.
- Conditions
- Interventions
- Sponsor
- Parc de Salut Mar
- Collaborators
- Carlos III Health Institute
- Start date
- 2024-09-03
- Primary completion
- 2026-07-31
- Sex
- Male
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Spain
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06606067