Overview

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

Status:
ACTIVE_NOT_RECRUITING

Trial end date:
2026-12-31

Target enrollment:

Participant gender:

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.

Phase:

PHASE3

Details

Lead Sponsor:

Parc de Salut Mar

Collaborator:

Carlos III Health Institute

Treatments:

Duloxetine Hydrochloride