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ACTIVE NOT RECRUITING
NCT06606067
PHASE3

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

Sponsor: Parc de Salut Mar

View on ClinicalTrials.gov

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.

Official title: Efficacy of Perioperative Duloxetine in Patients at High Risk for Developing Chronic Postsurgical Pain After Inguinal Hernia Repair: a Multicenter Randomized Controlled Trial.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

294

Start Date

2024-09-03

Completion Date

2026-12-31

Last Updated

2024-09-20

Healthy Volunteers

No

Interventions

DRUG

Duloxetine

30 mg daily 2 weeks before surgery and 1 week after surgery

DRUG

Placebo

Placebo tablet daily

Locations (1)

Hospital del Mar

Barcelona, Spain