Study on the Effect of Ketoprofen and Drug Combination for Managing Pain After Heart Surgery in Patients

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What is this study about?

This clinical trial is focused on managing postoperative pain after cardiac surgery. The study will explore the effectiveness of different medications in reducing pain following heart surgery. The medications being studied include Ketoprofen, Nefopam, Paracetamol, Tramadol, and Sodium Chloride. These medications are administered as solutions for injection or infusion, which means they are given directly into the bloodstream through a needle.

The purpose of the study is to determine if using nonsteroidal anti-inflammatory drugs (NSAIDs) can help reduce pain 24 hours after heart surgery. Participants in the study will receive one of the medications or a placebo. The study will monitor pain levels at rest and during activities like chest physiotherapy, which is a type of exercise to help improve breathing. Pain will be measured using a numerical rating scale, where patients rate their pain from 0 (no pain) to 10 (worst pain possible).

The study will last for a period of time after surgery, with pain assessments conducted daily from the first to the seventh day. Additional assessments will include checking for nausea, any lung complications, and chronic pain at 48 hours and three months after surgery. The quality of life will also be evaluated three months after surgery using a questionnaire. This trial aims to provide valuable insights into pain management for patients undergoing heart surgery.

1 joining the study

Upon joining the study, the patient must be 18 years or older and admitted for planned heart surgery with the use of a heart-lung machine.

The patient must provide signed informed consent to participate in the trial.

2 surgery and initial treatment

The patient undergoes cardiac surgery. Post-surgery, the patient receives medications to manage pain.

Medications include nefopam, paracetamol, ketoprofen, tramadol, and sodium chloride administered through infusion or injection.

3 pain assessment at 24 hours

Postoperative pain is evaluated 24 hours after surgery using a numerical rating scale (NRS) from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.

4 daily pain assessment

Pain is assessed daily from the first to the seventh day after surgery between 8 a.m. and 12 p.m. using the NRS.

The pain trajectory is monitored, focusing on changes in pain levels from day 3 to day 7.

5 additional assessments

During chest physiotherapy, pain is assessed similarly to the primary endpoint using the NRS.

Nausea is recorded using a verbal scale: none, moderate, or severe.

Postoperative lung complications are checked within the first 7 days after surgery based on European consensus definitions.

6 chronic and neuropathic pain assessment

Chronic pain is evaluated at 48 hours and again at 3 months using a concise pain questionnaire and the DN4 scale.

Neuropathic pain is assessed at 48 hours post-surgery.

7 quality of life assessment

Quality of life is assessed at 3 months using the EQ-5D-5L questionnaire, compared to the assessment conducted the day before surgery.

Who Can Join the Study?

Patient must be 18 years or older.
Patient is scheduled for planned heart surgery using a method called extracorporeal circulation, which means the blood is temporarily diverted outside the body to a machine that does the work of the heart and lungs during surgery.
Patient must have signed an informed consent, which is a document that explains the study and confirms the patient agrees to participate.
Both men and women can participate.
Patient should not belong to a vulnerable population, which means groups that might need special protection or care.

Who Cannot Join the Study?

Patients who have not undergone cardiac surgery.
Patients who do not experience pain after cardiac surgery.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who have any medical condition that the study does not focus on.
Patients who are not able to follow the study procedures or instructions.
Patients who are allergic to NSAIDs, which are medicines used to reduce pain and inflammation.
Patients who are taking other medications that might interfere with the study treatment.
Patients who have a history of certain medical conditions that could affect 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
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	17.02.2024

Trial locations

Investigated drugs:

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) are used in this trial to help manage pain after cardiac surgery. These medications work by reducing inflammation and pain in the body. They are commonly used to relieve pain from various conditions, including surgery, and are being tested here to see how effective they are in reducing pain 24 hours after heart surgery.

Investigated diseases:

Procedural pain

Postoperative Pain After Cardiac Surgery – This condition refers to the pain experienced by patients following cardiac surgery. It typically arises due to the surgical incision and manipulation of tissues during the procedure. The pain is often most intense in the first 24 hours post-surgery and can vary in intensity. It may be exacerbated by activities such as coughing or deep breathing, which are necessary for recovery. Over time, the pain generally decreases, but it can persist for several days or even weeks. In some cases, patients may experience chronic pain if the acute pain is not effectively managed.

Trial ID:

2023-506299-28-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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