Not recruiting

Study on Improving Pain Relief After Surgery Using Tramadol and Dexketoprofen Based on Genetic Testing for Patients with Acute Postoperative Pain

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial focuses on improving the treatment of acute postoperative pain, which is the pain experienced after surgery. The study is investigating the use of a genetic test called CYP2D6 genotyping to see if it can help make the pain medication tramadol work better and be safer for patients. Tramadol is a common pain reliever used after surgeries. The trial will also involve other medications like dexketoprofen, metamizole, and paracetamol, which are also used to manage pain.

The purpose of the study is to find out if using genetic information can help doctors choose the best pain treatment for each patient, making it more effective and reducing side effects. Participants in the study will be randomly assigned to receive either the standard pain treatment or a treatment plan based on their genetic test results. This will help researchers understand if the genetic test can improve pain management.

During the study, participants will take the medications orally, which means they will swallow them as pills or capsules. The study will last for a short period, up to three days, which is typical for managing pain after surgery. By comparing the outcomes of the different treatment plans, the study aims to provide insights into whether genetic testing can be a useful tool in personalizing pain management for better results.

The research process

The trial runs in 5 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, participants will be required to provide written consent, confirming their agreement to participate in the trial.
Participants must be over 18 years of age and scheduled for outpatient surgical extraction of at least two impacted third molars, with at least one requiring bone removal.
Step 2
Genetic testing
Participants will undergo a genetic test to determine their CYP2D6 genotype. This test helps in understanding how the body processes certain medications.
Step 3
Medication administration
Participants will receive medications to manage acute postoperative pain. The medications include Dexketoprofen 25 mg film-coated tablets, Tramadol 50 mg or 100 mg hard capsules, Metamizole 575 mg hard capsules, and Paracetamol 500 mg tablets.
The dosage and frequency of each medication will be determined based on the participant's genetic test results and the standard clinical practice for managing postoperative pain.
Step 4
Monitoring and follow-up
Participants will be monitored for the effectiveness and safety of the pain management regimen. This includes regular check-ins to assess pain levels and any side effects experienced.
The study aims to evaluate if using genetic information can improve pain treatment by increasing efficacy and reducing adverse reactions.
Step 5
Completion of the study
The study is expected to continue until April 30, 2023. Participants will be informed about the completion of the study and any relevant findings that may impact their ongoing care.

Who can join the trial?

3 criteria

Men or women over 18 years of age.
Patients scheduled for outpatient surgical extraction of at least two impacted third molars. This means you are having a procedure to remove two or more wisdom teeth that have not come through the gums properly, and at least one of these teeth will need some bone to be removed.
Patients who agree to participate in the study and give written consent. This means you understand the study and are willing to sign a form saying you agree to take part.

Who cannot join the trial?

8 criteria

Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means groups that might need special protection or care.
Patients who have medical conditions that are not related to the study's focus on **pharmacogenetics** or **acute postoperative pain**.
Patients who are not able to follow the study procedures or instructions.
Patients who are currently participating in another clinical trial.
Patients who have a history of allergic reactions to medications used in the study.
Patients who are pregnant or breastfeeding.
Patients who have a serious medical condition that might interfere with the study results.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital Clinico San Carlos
Verified
Madrid, Spain
Hospital Universitario 12 De Octubre
Verified
Madrid, Spain

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Tramadol is a medication used to help relieve moderate to severe pain. It works by changing the way your brain senses pain, making it feel less intense. In this clinical trial, tramadol is being studied to see if its effectiveness and safety can be improved by using genetic testing. This means that doctors might be able to predict how well tramadol will work for you and if you might experience any side effects, based on your genetic makeup.

What is already known about the treatment

Tramadol – Tramadol is a medication administered orally, typically in the form of tablets or capsules, and is used to manage moderate to severe pain, such as acute postoperative pain. It is currently well-established in medical practice and literature, particularly in the context of pain management. The main therapeutic indication for tramadol is the relief of acute pain following surgery. At the molecular level, tramadol works by binding to specific receptors in the brain and spinal cord, known as opioid receptors, and also inhibits the reuptake of neurotransmitters like serotonin and norepinephrine, which helps to reduce the perception of pain. It is classified pharmacologically as an opioid analgesic.

Investigated diseases

Acute Postoperative Pain – Acute postoperative pain is a type of pain that occurs after surgical procedures. It is typically sharp and intense, resulting from tissue damage and inflammation caused by the surgery. The pain usually begins immediately after the operation and can last for a few days to weeks, depending on the type and extent of the surgery. It progresses as the body heals, with pain intensity generally decreasing over time. The pain can be influenced by factors such as the patient's pain threshold, the surgical technique used, and the presence of any complications. Effective management is crucial to prevent the transition to chronic pain.