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Study on Preventing Chronic Pain After Hernia and Knee Surgery Using Tapentadol for Patients Undergoing These Surgeries

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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 the prevention of chronic postoperative pain, which is pain that persists after surgery, specifically following inguinal hernia surgery and knee replacement surgery. The treatment being tested in this study is a medication called Tapentadol, which is provided in the form of a prolonged-release tablet known as PALEXIA Retard 50 mg. This medication is taken orally, meaning it is swallowed. The study also involves a comparison with a placebo to evaluate the effectiveness of Tapentadol in preventing chronic pain after surgery.

The purpose of the study is to explore whether using Tapentadol after surgery can help prevent the development of chronic pain in patients who have undergone inguinal hernia or knee replacement surgeries. Participants in the study will receive either Tapentadol or a placebo after their surgery. The study will monitor the development of chronic pain over the course of the first year following the surgery to determine the effectiveness of the treatment.

By participating in this study, researchers aim to gain a better understanding of how chronic postoperative pain develops and whether Tapentadol can be an effective treatment to prevent it. The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo, ensuring unbiased results. The trial is expected to continue until early 2026.

The research process

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

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age between 18-80 years and an American Society of Anesthesiologists score of 1, 2, or 3.
Step 2
Surgery preparation
Preparation for either inguinal hernia surgery or knee replacement surgery is undertaken. This involves standard pre-surgical procedures.
Step 3
Surgery
The patient undergoes the planned surgical procedure, which is either inguinal hernia surgery or knee replacement surgery.
Step 4
Postoperative treatment
Following surgery, the patient receives postoperative treatment with tapentadol hydrochloride or a placebo. The medication is administered orally in the form of a prolonged-release tablet known as PALEXIA Retard 50 mg.
The dosage and frequency of administration are determined by the study protocol and are designed to prevent the development of chronic postoperative pain.
Step 5
Monitoring and follow-up
The patient's response to the treatment is monitored over the course of one year. This includes regular assessments to evaluate the effect of tapentadol compared to the placebo on the development of chronic pain.
The study aims to understand the mechanism behind the development of chronic postoperative pain.
Step 6
Completion of study
The study is estimated to conclude by January 1, 2026. At this point, the final assessments are conducted to gather data on the primary endpoint, which is the effect of the treatment on chronic pain development.

Who can join the trial?

4 criteria

Must have an American Society of Anesthesiologists score of 1, 2, or 3. This score is a way to describe a patient's overall health before surgery, with 1 being healthy and 3 having more health issues.
Must be between the ages of 18 and 80 years old.
Both men and women can participate.
Participants should not be from a vulnerable population, meaning they should not be in a situation where they are at a higher risk of harm or exploitation.

Who cannot join the trial?

4 criteria

Patients who are not undergoing inguinal hernia surgery or knee replacement surgery.
Patients who are not experiencing or at risk of developing chronic postoperative pain. This is pain that continues for a long time after surgery.
Patients who are outside the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

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Reinier de Graaf Groep
Delft, The Netherlands

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Investigated drugs

Tapentadol is a medication used in this trial to prevent chronic pain after surgery. It is an opioid pain reliever that works by changing the way the brain and nervous system respond to pain. In this study, it is being tested to see if it can help reduce the risk of developing long-term pain after surgeries like inguinal hernia repair and knee replacement.

Tapentadol Hydrochloride

What is already known about the treatment

Tapentadol – Tapentadol is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in preventing chronic postoperative pain, particularly after surgeries like inguinal hernia and knee replacement. The main therapeutic indication for Tapentadol is pain management, specifically targeting moderate to severe pain. At the molecular level, Tapentadol works by binding to certain receptors in the brain and spinal cord, which helps to reduce the perception of pain. It is classified pharmacologically as an opioid analgesic, which means it is a type of medication used to relieve pain.

Investigated diseases

Chronic Postoperative Pain – This condition occurs when pain persists for an extended period following surgery, beyond the usual healing time. It can develop after various surgical procedures, such as inguinal hernia repair or knee replacement. The pain may be continuous or intermittent and can vary in intensity. It often results from nerve damage or changes in the nervous system due to surgery. Over time, this pain can affect a person's daily activities and quality of life. Understanding the mechanisms behind its development is crucial for prevention and management.