Clinical Trial

Duloxetine to Prevent Chronic Postsurgical Pain After Inguinal Hernia Repair in Patients at High Risk

Study acronym: GENDOLCAT3
Active, Not Recruiting Phase 3
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Record status
This record was last updated September 20, 2024 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT06606067
Lead Sponsor Parc de Salut Mar
Collaborators: Carlos III Health Institute
Conditions Chronic Post-surgical Pain
Enrollment 294 participants
Start Date 2024-09-03
Primary Completion 2026-07-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-09-20