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Efficacy of perioperative duloxetine in patients at high risk for developing chronic postsurgical pain after inguinal hernia repair: a multicenter randomized controlled trial
EU CTIS ID: 2023-505860-12-00
What this study is testing
To determine the efficacy of duloxetine versus placebo in reducing the incidence of CPSP at 4 months in patients at high risk of this complication
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men that live in Spain during the entire trial and who are scheduled for open inguinal hernia repair (inpatient or outpatient procedures).
- Risk of post-surgical pain chronification ≥ 16% using the GENDOLCAT risk scale.
You likely can't join if
- Age under 18 years
- History of liver failure (Child-Pug B or C)
- 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 CYP1A2: fluvoxamine, ciprofloxacin or enoxacin
- History of uncontrolled hypertension
See the full eligibility criteria
- Men that live in Spain during the entire trial and who are scheduled for open inguinal hernia repair (inpatient or outpatient procedures).
- Risk of post-surgical pain chronification ≥ 16% using the GENDOLCAT risk scale.
- Age under 18 years
- History of liver failure (Child-Pug B or C)
- 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 CYP1A2: fluvoxamine, ciprofloxacin or enoxacin
- History of uncontrolled hypertension
- History of bipolar disorder
- History of seizures over 18 years of age, not during chilhood for febrile seizures
- Clinical record of acute glaucoma
- Treatment with selective serotonin reuptake inhibitors (SSRIs)
- Treatment with serotonin and noradrenaline reuptake inhibitors (SNRIs)
- Patients who in the recruiter’s opinion have insufficient knowledge of Spanish to understand the trial
- Treatment with tricyclic antidepressants
- Treatment with triptans
- Treatment with antipsychotic drugs
- Treatment with dopamine antagonists
- Treatment with oral anticoagulant agents
- Treatment with St. John's Wort (Hypericum perforatum)
- History of Major depression disorder
- History of Generalized anxiety disorder
- Patients who are currently being treated with duloxetine
- Patients with known allergy to duloxetine or hypersensitivity to any of the excipients
- Serious renal failure (creatinine clearance >30 ml/min in blood test during 3 months before surgery)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.