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

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What is this study about?

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.

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 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 surgery

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

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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain

Other Sites

Site Name	City	Country
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Consorci Sanitari Del Maresme	Mataró	Spain
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada	Manresa	Spain
Hospital Son Llatzer	Palma	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Hvrivwpz Uuuvedifqackn Hbrqznnl Tlkpi y Pzxddj Iseowglj Cqcgmu dzvvcaekhsyxgarfl (eags	Badalona	Spain
Hvlrwmlj Vrtc dytqfxsi	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	02.10.2023

Trial locations

Investigated drugs:

Duloxetine

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.

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 ID:

2023-505860-12-00

Protocol code:

ICI21/00006l

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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