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

Study acronym: GENDOLCAT3
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Study First Submitted
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
(from sponsor)		 Chronic Post-surgical Pain
Related terms Postoperative Pain
Enrollment 294 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov