AuthorisedTherapeutic confirmatory (Phase III)Interventional

Efficacy of intravenous dexamethasone in prolonging the duration of spinal anesthesia with chloroprocaine in knee arthroscopy.

This study is investigating if adding a medicine called dexamethasone to a spinal anaesthetic (a type of injection to numb the lower body) can make the numbing effect last longer during and after knee arthroscopy, which is a common keyhole knee surgery. Researchers want to see if patients stay pain-free for a longer period. They will be measuring how long it takes for a patient to start feeling sensation again in certain areas of their body after the anaesthetic, using a gentle pin-prick test. The study also tracks how long it takes for movement to fully return and whether patients need extra pain relief during surgery. This is a Phase 3 study, meaning it's a key step in testing how well this approach works and if it's safe for wider use.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Medico Chirurgical Ambroise Pare Hartmann

Enrolment target

Start

08 Apr 2026

Knee arthroscopy

What is this study about?

This study is about making sure you're as comfortable as possible during and after a routine knee keyhole surgery, called a knee arthroscopy. When you have this type of surgery, doctors often use a spinal anaesthetic. This is an injection in your back that numbs your lower body, so you don't feel pain during the operation.

The main aim of this research is to see if adding a widely used anti-inflammatory medicine called dexamethasone to the spinal anaesthetic can make the numbing effect last longer. If it does, it means you might stay pain-free for a greater period after surgery, potentially leading to a more comfortable recovery right from the start.

To find this out, the research team will carefully measure how long it takes for the numbing sensation to start wearing off. They do this by gently checking your skin sensation with a small pin-prick at different times after your anaesthetic. They'll also check when feeling and movement fully return to your legs. This is an important step in improving how we manage pain for patients undergoing knee surgery.

Key takeaways

This study aims to make your knee surgery recovery more comfortable.
It investigates if an added medicine can extend pain relief from spinal anaesthetic.
Participation involves routine checks of sensation and movement after surgery.
Your comfort and safety are the top priority throughout the study.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To take part in this study, you need to be an adult, 18 years old or older. Both men and women are welcome to participate. The study is specifically for people who are having a knee arthroscopy, which is a common keyhole surgery on the knee.

There might be certain health conditions or medications that would prevent you from joining, but these details are usually discussed with the study team. The main idea is to include people who are generally suitable for a spinal anaesthetic and knee surgery.

It's important that you understand what's involved and are happy to take part. The study team will explain everything to you in full before you make a decision.

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 knee arthroscopy (keyhole knee surgery)?
Are you generally healthy enough for a spinal anaesthetic and surgery?
Are you able to understand and be happy to take part in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be receiving a standard spinal anaesthetic for your knee arthroscopy, but with a potential addition of the study medicine, dexamethasone, or a dummy medicine (placebo). Before, during, and after your surgery, the research team will regularly check how well the anaesthetic is working. This involves simple tests like a gentle pin-prick on your skin to see if you can feel sensation, and checking how well you can move your legs.

These checks happen frequently at first – every 5 minutes after your spinal injection – and then less often as the anaesthetic starts to wear off, usually every 10 minutes until you can fully move your legs again. The total duration of your active participation will mostly be during your hospital stay for the surgery itself and while the anaesthetic effects are being monitored until they wear off completely, usually within a few hours.

Potential risks and benefits

Taking part in this study might benefit you by potentially extending the pain relief from your spinal anaesthetic, leading to a more comfortable recovery after your knee surgery. However, there's no guarantee you'll receive the active medicine; you might receive a placebo. As with any medical procedure, there are potential risks, such as side effects from the medicines or issues related to the spinal anaesthetic, but these will be fully explained by the medical team. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What exactly is a knee arthroscopy?

A knee arthroscopy is a common 'keyhole' surgery on the knee. Doctors use small cuts and a tiny camera to look inside and fix problems in your knee joint.

What is a spinal anaesthetic?

A spinal anaesthetic is an injection in your back that numbs your body from the waist down, so you won't feel any pain during your knee surgery.

What is dexamethasone?

Dexamethasone is a common anti-inflammatory medicine often used to reduce swelling and pain. In this study, we're seeing if it can make the numbing effect of the anaesthetic last longer.

Will I know if I'm getting the active medicine or a dummy medicine?

No, this is a 'blinded' study, meaning neither you nor your doctors will know whether you receive dexamethasone or a dummy medicine. This helps make the study results as fair and accurate as possible.

What if I feel pain during the surgery?

If you experience any pain during the surgery, the medical team will provide additional pain relief or anaesthesia immediately to ensure your comfort and safety.