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Study on Nefopam for Reducing Postoperative Pain in Adults After Total Knee Replacement Surgery

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What is this study about?

This clinical trial is focused on studying the effects of a medication called nefopam on managing postoperative pain after a total knee replacement surgery. The study aims to determine if taking nefopam by mouth can reduce the need for morphine, a common pain relief medication, within the first 24 hours after surgery. Participants in the study will be randomly assigned to receive either nefopam or a placebo, which is a substance with no active medication.

During the trial, participants will undergo their scheduled knee replacement surgery and will be monitored for their pain levels and morphine consumption. The study will also assess various aspects of pain, such as the intensity and sensitivity to pressure, as well as any side effects experienced. Blood and spinal fluid samples may be collected to measure the concentration of nefopam and its breakdown products in the body.

The goal of this research is to explore whether nefopam can effectively reduce the amount of morphine needed for pain relief after surgery, potentially offering a new approach to managing postoperative pain. The study is expected to continue until 2026, with recruitment starting in 2024.

1 joining the study

Participation begins after signing the informed consent form. Eligibility includes being over 18, scheduled for knee surgery, and having an ASA score between I and III.

2 surgery and initial treatment

Undergo total knee replacement surgery with spinal anesthesia. Initial pain management involves morphine administered through intravenous injection.

3 nefopam administration

Receive nefopam orally after surgery. This medication is intended to reduce the need for morphine within the first 24 hours post-surgery.

4 pain assessment

Pain levels are monitored using various measures, including pressure pain threshold and punctate pain intensity. The total morphine consumption is recorded within 24 hours after surgery.

5 safety and efficacy evaluation

Safety outcomes are self-reported and measured. Blood and cerebrospinal fluid samples may be taken to assess concentrations of nefopam and its metabolites.

6 follow-up

Persistent postoperative pain is evaluated using specific questionnaires. Follow-up visits are required to monitor recovery and any long-term effects.

Who Can Join the Study?

  • Patient over 18 years old.
  • Patient scheduled for a primary total knee replacement surgery under spinal anesthesia at the orthopedics department of the Croix-Rousse hospital.
  • Patient with an American Society of Anesthesiology (ASA) score between I and III. The ASA score is a way to assess the physical health of a patient before surgery, with I being healthy and III having more serious health issues.
  • Patient who has agreed to participate in the study and has signed the informed consent form. This form explains the study and confirms the patient’s willingness to join.
  • Patient entitled to social security benefits.
  • Patient willing to return for all study visits.

Who Cannot Join the Study?

  • Patients who are not experiencing postoperative pain after a total knee replacement surgery. This means if you haven’t had knee surgery recently, you can’t participate.
  • Patients who are not adults. This study is only for adults, so if you are under 18, you cannot join.
  • Patients who are part of a vulnerable population. This refers to groups of people who might need special protection, like pregnant women or people with certain disabilities.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Cee Ckctv Rdqygrtmkpz Lyon France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
29.06.2024

Trial locations

Investigated drugs:

Nefopam is a medication being tested in this trial to see if it can help reduce the need for morphine after knee replacement surgery. It is taken by mouth and is being studied for its ability to manage pain effectively after the operation. The goal is to see if patients who take nefopam need less morphine, which is a strong painkiller, in the first 24 hours after their surgery.

Postoperative Pain After a Total Knee Arthroplasty – This condition refers to the pain experienced by patients following a surgical procedure to replace the knee joint, known as total knee arthroplasty. The pain typically arises due to the surgical trauma to tissues, including bones, muscles, and nerves. It can vary in intensity and may be influenced by factors such as the patient’s pain threshold and the extent of the surgery. The pain is usually most intense immediately after the surgery and tends to decrease over time as the healing process progresses. Managing this pain is crucial for patient comfort and to facilitate rehabilitation and recovery.

Trial ID:
2024-513796-40-00
Protocol code:
69HCL20_0111
NCT ID:
NCT04576078
Trial Phase:
Phase II and Phase III (Integrated)

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