Not yet recruitingPHASE3INTERVENTIONAL

Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO)

This study, called NEFARTHRO, is looking at the best way to manage pain after a total hip replacement. Researchers are comparing two different methods of giving a pain relief medicine called nefopam: either a continuous drip (infusion) or smaller, top-up doses (bolus). They are also comparing these methods to a dummy treatment (placebo). All patients will also receive standard painkillers like paracetamol and anti-inflammatory drugs. The main goal is to see which approach helps patients use the least amount of strong painkillers, like morphine, in the first 24 hours after surgery. Doctors will also follow patients for six months to see how they recover.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

University Hospital, Tours

Enrolment target

546

Start

01 Apr 2024

Estimated completion

01 Apr 2027

Total Hip Arthroplasty

What is this study about?

When you have an operation like a hip replacement, managing pain afterwards is really important. Strong painkillers, often called opioids (like morphine), are very good at controlling pain, but doctors want to make sure patients use only what they need. This is where other medicines come in to help reduce the amount of strong pain relief required.

This study is focusing on a painkiller called nefopam. It's not an opioid, but it can help manage pain and reduce the need for stronger medications. The study wants to find out the best way to give nefopam after a hip replacement: is it better as a steady drip throughout the day, or as smaller, occasional doses when needed? They're comparing these against a dummy treatment (placebo) to truly understand nefopam's benefits.

The main thing the doctors will measure is how much strong pain relief (like morphine) you might need in the first 24 hours after your surgery. They will also keep an eye on your recovery and pain levels for up to six months after the operation. This research aims to improve pain management for people having hip replacements in the future.

Key takeaways

This study evaluates different ways to give nefopam for pain after hip replacement.
It aims to find out which method best reduces the need for strong painkillers.
Patients are randomly assigned to receive nefopam continuously, as top-ups, or a dummy treatment.
All participants also receive standard painkillers like paracetamol.
Your progress will be monitored for six months after the operation.

Who may be eligible?

To join this study, you need to be at least 18 years old and be planning to have your hip replaced for the first time or a redo. You must also be able to understand French and agree to take part by signing a consent form. Everyone in the study will receive common painkillers like paracetamol and ketoprofen after surgery.

There are several reasons why you might not be able to join. For example, if you're having an operation for an infection or cancer, or if you're allergic to nefopam, paracetamol, or anti-inflammatory drugs. Certain existing health problems, like severe liver or heart conditions, very poor kidney function, uncontrolled glaucoma, or a history of fits, would also mean you can't participate.

Additionally, if you're pregnant or breastfeeding, or if you're already taking strong opioid painkillers for long-term pain (not just because of your hip problem), you wouldn't be able to be part of this research. It's also important that you can understand and rate your own pain.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having a hip replacement surgery?
Do you speak and understand French?
Are you not pregnant or breastfeeding?
Do you not have severe liver, heart, or kidney problems?
Are you able to understand and report your pain levels?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of three groups by chance, like flipping a coin. You won't know which group you're in, and neither will your doctors, to make the results fair. One group will receive nefopam as a continuous drip, another will get nefopam as top-up doses, and the third group will receive a dummy treatment (placebo) instead of nefopam.

All patients will receive standard pain relief like paracetamol and an anti-inflammatory drug. After your surgery, doctors will carefully monitor how much strong pain relief you need in the first 24 hours. You'll be asked about your pain levels regularly. After this initial 24-hour period, the study will continue to follow your recovery for six months, likely with check-up appointments or phone calls. The total duration of your involvement, including follow-up, will be six months.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit could be more effective pain control after your hip replacement, or a reduced need for strong opioid painkillers. However, there's no guarantee of direct benefit for you personally. Potential risks include side effects from nefopam or the other medications, though these are typically mild and your medical team will monitor you closely. Remember, you can choose to leave the study at any time without it affecting your usual medical care.

Locations (7)

Anaesthesia - Intensive care
Verified postcode
Angers, France
Anaesthesia - Intensive care
Verified postcode
Blois, France
Anaesthesia - Intensive care
Verified postcode
Chartres, France
Anaesthesia - Intensive care
Verified postcode
Nantes, France
Anaesthesia - Intensive care
Verified postcode
Orléans, France
Anaesthesia - Intensive care
Verified postcode
Poitiers, France
Anesthesia - intensive care
Verified postcode
Tours, France

Common questions

What is nefopam?

Nefopam is a pain-relieving medicine that is not an opioid. It works differently from drugs like morphine and can help reduce the need for stronger painkillers.

What is a 'placebo'?

A placebo is a dummy treatment, like a sugar pill or a saline drip, that looks exactly like the real medicine but contains no active drug. It helps researchers understand if the medicine itself is causing an effect, or if it's due to other factors.

Will I still get pain relief if I'm in the placebo group?

Yes, regardless of which group you're in, you will still receive standard pain relief after your surgery, including paracetamol and anti-inflammatory drugs. You will also be given strong painkillers if you need them.

How long will I be followed after the operation?

You will be followed for a full six months after your hip replacement surgery to check on your recovery and any long-term effects of your pain management.

Can I leave the study if I change my mind?

Yes, you are completely free to withdraw from the study at any time without giving a reason. Your decision will not affect the quality of your medical care.

How to find out more

Francis REMERAND, MD PhD

f.remerand@chu-tours.fr 02.47.47.85.51 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.