Efficacy of perioperative duloxetine in patients at high risk for developing chronic postsurgical pain after inguinal hernia repair: a multicenter randomized controlled trial

Phase 1

• Conditions: Chronic postsurgical pain after inguinal hernia repair; MedDRA version: 20.1Level: LLTClassification code: 10049475Term: Chronic pain Class: 10018065; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-505860-12-00
• Lead Sponsor: Parc De Salut Mar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-02
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 294

Inclusion 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 = 27% using the GENDOLCAT risk scale.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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;Secondary Objective: To compare the characteristics, intensity, and impact of CPSP on quality of life in the intervention and control groups., To assess safety by comparing the rates of adverse effects of perioperative duloxetine and placebo for the primary prevention of CPSP;Primary end point(s): Incidence of CSPS (Chronic post-surgical pain) at 4 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Quality of life by means of questionnaire SF-12;Secondary end point(s):Rate of adverse events perioperatively