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

NCT06606067 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2024-09-20

No results posted yet for this study

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.

Conditions

  • Chronic Post-surgical Pain

Interventions

DRUG

Duloxetine

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

DRUG

Placebo

Placebo tablet daily

Sponsors & Collaborators

  • Carlos III Health Institute

    collaborator OTHER_GOV

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • Antonio Montes, PhD · Hospital del Mar Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-03
Primary Completion
2026-07-31
Completion
2026-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06606067 on ClinicalTrials.gov