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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Area De Salud De Burgos Y Soria	Burgos	Spain
Htvtnyyj Ujmoqiyqmizjm Da Ln Pkkpcovj	Madrid	Spain
Fjisxeorh Plqr Lg Icoqukkpxemfk Bkmlcijhs Dyg Haymcesv Uksxxwvbmjtvg Ls Pzw	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	30.04.2022

Trial locations

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.

Investigated diseases:

Procedural pain

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.

Trial ID:

2022-500377-13-01

Protocol code:

Trial Phase:

Therapeutic confirmatory (Phase III)

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