Clinical Research Directory
Browse clinical research sites, groups, and studies.
Duloxetine to Prevent Chronic Postsurgical Pain After Inguinal Hernia Repair in Patients at High Risk
Sponsor: Parc de Salut Mar
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
Conditions
Interventions
Duloxetine
30 mg daily 2 weeks before surgery and 1 week after surgery
Placebo
Placebo tablet daily
Locations (1)
Hospital del Mar
Barcelona, Spain