Study on the Effects of Nefopam and Sodium Chloride for Pain Relief After Total Hip Replacement Surgery

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What is this study about?

This clinical trial is focused on studying the effects of the medication nefopam in managing pain after a total hip replacement, a surgery where the hip joint is replaced with a prosthetic implant. The study aims to evaluate how effective nefopam is when given in two different ways: as a series of small doses (bolus) or as a continuous infusion (IVSE), compared to a placebo. The goal is to see how these methods affect the need for morphine, a strong painkiller, within the first 24 hours after surgery. This is part of a pain management approach that also includes at least paracetamol and a type of anti-inflammatory drug known as NSAIDs.

Participants in the study will receive either nefopam or a placebo after their hip replacement surgery. The study will monitor the amount of morphine used for pain relief, as well as other factors like pain levels at rest and during movement, recovery of physical function, and any side effects from the medications. The study will also look at the long-term effects on pain and recovery, including how quickly participants can stop using walking aids like canes or crutches.

The safety of nefopam will be closely monitored, with attention to any serious side effects such as seizures, confusion, or allergic reactions. The study will also track any common side effects of morphine, such as nausea, itching, or urinary retention. Additionally, the study will assess the economic impact of using nefopam as part of a pain management strategy over a five-year period. The trial is expected to run until 2026, with recruitment having started in 2023.

1 joining the trial

Upon joining the clinical trial, the participant will be required to provide written consent. This consent confirms understanding and agreement to participate in the study.

2 surgery preparation

The participant will undergo a scheduled total hip replacement surgery. This procedure is necessary for the study and will be performed under general or spinal anesthesia.

3 post-surgery medication

After the surgery, the participant will receive a combination of medications for pain management. This includes paracetamol and ketoprofen.

Additionally, the participant will be administered nefopam through intravenous infusion. This can be given as a continuous infusion or in separate doses, known as boluses.

4 monitoring and assessment

The participant’s pain levels will be monitored using a simple numerical scale from 0 (no pain) to 10 (maximum pain). This will occur at rest and during movement, both in the recovery room and up to 24 hours after surgery.

The participant’s use of morphine for pain relief will be recorded, including any doses given in the recovery room.

5 functional recovery evaluation

The participant’s ability to walk, leave the room, and climb stairs will be assessed. This evaluation will take place 24 hours after surgery and on the fifth day or upon discharge.

A standardized questionnaire will be used to assess the participant’s recovery progress.

6 follow-up assessments

Six months after the surgery, the participant will be contacted by phone to evaluate any chronic pain at rest or during movement.

The participant will also be asked about any early or late nerve pain using a simplified questionnaire.

7 safety and side effects monitoring

Throughout the trial, any serious side effects related to nefopam will be recorded. This includes seizures, confusion, or severe allergic reactions.

The participant will also be monitored for common side effects of morphine, such as nausea, vomiting, itching, or urinary retention.

Who Can Join the Study?

Patient must be 18 years or older and speak French fluently.
Scheduled to receive a total hip replacement, whether it is the first time or a revision, regardless of the surgical approach or type of prosthesis.
Will receive paracetamol (a common pain reliever) and ketoprofen (a type of anti-inflammatory medication) after surgery.
Undergoing general anesthesia or spinal anesthesia (without morphine injected into the spinal fluid).
Must be affiliated with a social security system.
Must provide free, informed, and written consent to participate in the study.

Who Cannot Join the Study?

Patients who have had a total hip replacement 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 are not able to give their own consent to participate in the study.
Patients who have any medical condition that might interfere with the study or make it unsafe for them to participate.
Patients who are currently participating in another clinical trial.
Patients who have allergies or adverse reactions to the medications being tested in the study.
Patients who are pregnant or breastfeeding.
Patients who have a history of substance abuse or addiction.
Patients who have a serious mental health condition that might affect their ability to participate in the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Centre Hospitalier Blois Simone Veil	Blois	France
Centre Hospitalier Universitaire d’Orléans	Orléans	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Les Hopitaux De Chartres	Le Coudray	France
Cvgw dy Tfwxbc Hdttkuf Tkhetzqxf	Chambray Les Tours	France
Cmtdzh Hrnqfmbtvey Rdxajkpf Devgncxxsfpqgq	Angers	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	20.09.2023

Trial locations

Investigated drugs:

Nefopam is a medication used to help manage pain. In this clinical trial, it is being tested to see how well it works in reducing the need for other pain medications, like morphine, after hip replacement surgery. Nefopam can be given in two different ways: as a series of small doses or as a continuous infusion. The goal is to find out which method is more effective in controlling pain.

Paracetamol, also known as acetaminophen, is a common pain reliever and fever reducer. In this trial, it is part of a combination of treatments used to manage pain after hip replacement surgery. It helps to reduce pain and discomfort, making it easier for patients to recover.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are a group of medications that help reduce inflammation, pain, and fever. In this trial, an NSAID is used alongside other pain management strategies to help control pain after hip replacement surgery. These drugs work by reducing the substances in the body that cause inflammation and pain.

Total Hip Arthroplasty – Total Hip Arthroplasty is a surgical procedure where a damaged hip joint is replaced with an artificial one. The disease progression involves the deterioration of the hip joint due to conditions like osteoarthritis, rheumatoid arthritis, or traumatic injury. Over time, the cartilage that cushions the hip joint wears away, leading to pain and stiffness. As the condition progresses, individuals may experience increased difficulty in walking and performing daily activities. The surgery aims to relieve pain and restore function by replacing the damaged joint surfaces with prosthetic components. Post-surgery, patients typically undergo rehabilitation to regain mobility and strength in the hip.

Trial ID:

2023-504079-26-01

Protocol code:

NEFARTHRO

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Nefopam and Sodium Chloride for Pain Relief After Total Hip Replacement Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?