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Study on Duloxetine for Reducing Chronic Pain After Inguinal Hernia Surgery in High-Risk Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying chronic postsurgical pain that can occur after an inguinal hernia repair, which is a common surgical procedure to fix hernias in the groin area. The study is investigating the effectiveness of a medication called duloxetine, which is often used to treat depression and anxiety, but in this case, it is being tested to see if it can help reduce the risk of developing chronic pain after surgery. Participants in the study will receive either duloxetine or a placebo, which is a substance with no active medication, to compare the outcomes.

The purpose of the study is to determine if taking duloxetine around the time of surgery can lower the chances of experiencing long-term pain four months after the operation. The study will involve patients who are considered at high risk for developing chronic pain after their hernia repair. These patients will be monitored over a period to assess the incidence of chronic pain and any changes in their quality of life, as well as to record any side effects that may occur during the study.

Participants will be randomly assigned to receive either duloxetine or a placebo, and they will take the medication orally in the form of capsules. The study will track their progress and gather data on their pain levels and overall well-being. The findings from this trial could provide valuable insights into managing chronic pain after surgery and potentially improve recovery outcomes for patients undergoing inguinal hernia repair.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after being scheduled for open inguinal hernia repair surgery. Eligibility requires living in Spain throughout the trial and having a risk of post-surgical pain chronification of 27% or higher, as determined by the GENDOLCAT risk scale.

  2. Step 2

    Pre-surgery medication

    Before surgery, receive either a duloxetine capsule or a placebo. Duloxetine is a medication used to manage pain and is administered in a 30 mg dose. The capsule is taken orally and is designed to resist stomach acid, ensuring it reaches the intestines before dissolving.

  3. Step 3

    Surgery

    Undergo the scheduled open inguinal hernia repair surgery. This procedure may be performed as an inpatient or outpatient operation.

  4. Step 4

    Post-surgery medication

    Continue taking the assigned capsule (duloxetine or placebo) as directed by the study protocol. The frequency and duration of administration will be specified by the study team.

  5. Step 5

    Follow-up assessments

    Participate in follow-up assessments to evaluate the incidence of chronic post-surgical pain (CPSP) at 4 months after surgery. This includes completing the SF-12 questionnaire to assess quality of life and reporting any adverse events experienced during the perioperative period.

  6. Step 6

    End of study participation

    Study participation concludes after the final assessment at 4 months post-surgery. The trial is estimated to end by October 1, 2027.

Who can join the trial?

3 criteria

  • Participants must be men who live in Spain for the entire duration of the trial.
  • Participants should be scheduled for open inguinal hernia repair, which is a type of surgery to fix a hernia in the groin area. This can be done as an inpatient (staying in the hospital) or outpatient (not staying overnight) procedure.
  • Participants must have a risk of developing **chronic post-surgical pain** of 27% or higher, as measured by the GENDOLCAT risk scale. This scale helps to predict the likelihood of experiencing long-term pain after surgery.

Who cannot join the trial?

3 criteria

  • Patients who are not at high risk of developing chronic postsurgical pain after inguinal hernia repair. This means if you are not likely to have long-lasting pain after this type of surgery, you cannot participate.
  • Patients who are not within the specified age range for the study. The study is looking for participants in certain age groups, so if you are too young or too old, you may not be eligible.
  • Patients who belong to a vulnerable population. This means if you are in a group that needs special protection or care, you might not be able to join the study.
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Investigated drugs

Duloxetine is a medication being studied for its ability to reduce the risk of developing chronic pain after surgery. In this trial, it is being tested on patients who are having inguinal hernia repair surgery and are at high risk of experiencing long-term pain after the procedure. The goal is to see if taking duloxetine can help decrease the chances of this pain occurring four months after the surgery.

What is already known about the treatment

Duloxetine – Duloxetine is typically administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in reducing chronic postsurgical pain, particularly after inguinal hernia repair. The main therapeutic indication for duloxetine in this context is to alleviate chronic pain that persists after surgery. At the molecular level, duloxetine works by inhibiting the reuptake of serotonin and norepinephrine, which are neurotransmitters involved in pain modulation. It is classified pharmacologically as a serotonin-norepinephrine reuptake inhibitor (SNRI).

Investigated diseases

Chronic Postsurgical Pain after Inguinal Hernia Repair – This condition refers to persistent pain that occurs after surgery to repair an inguinal hernia, lasting for more than three months. It is characterized by discomfort or pain in the area where the surgery was performed, which can vary in intensity and may interfere with daily activities. The pain is not due to any ongoing tissue damage or surgical complications but is thought to result from changes in the nervous system. Over time, the pain may become less intense, but in some cases, it can persist and affect the individual's quality of life. The exact cause of this chronic pain is not fully understood, but it is believed to involve nerve irritation or damage during the surgical procedure.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505860-12-00Protocol codeICI21/00006lEstimated enrolment294 patientsSponsorConsorci Mar Parc De Salut De Barcelona

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