Duloxetine: 30 mg daily 2 weeks before surgery and 1 week after surgery
Placebo: Placebo tablet daily
Study summary
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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Efficacy of duloxetine versus placebo in reducing the incidence of Chronic Post-Surgical Pain (CPSP) at 4 months — 4 months after surgery The primary outcome will be a change in the Chronic Post-Surgical Pain (CPSP) incidence at 4 months in the intervention group compared to the placebo group with an odds ratio of 0.44 as the effect size. Criteria of CPSP: 1) The pain develops after a surgical procedure or increases in intensity after the surgical procedure, 2) the pain should be of at least 3 months' duration and significantly affected the quality of life, 3) the pain is either a continuation of acute post-surgery pain or develops after an asymtomatic period, 4) the pain is either localized to the surgical field, projected to the innervation territory of a nerve situated in the surgical field, or referred to a dermatome, 5) other causes of the pain should be excluded: infection or continuing malignancy in cancer surgery.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.