AuthorisedTherapeutic confirmatory (Phase III)Interventional

A phase III, randomized, double-blind study assessing the efficacy and safety of intravenous lidocaine versus placebo in patients receiving intrathecal morphine analgesia in major digestive or abdominal surgery by laparotomy

This research study is for people having a big operation on their tummy. After this type of surgery, patients often receive strong pain relief called morphine through a special tube in their spine. This study wants to see if adding another medicine, called lidocaine (given through a vein), can help reduce the total amount of morphine needed to keep pain under control. We will compare lidocaine to a placebo (a dummy medicine with no active ingredients). The study will also carefully check for any side effects and how well patients recover, including how long they stay in hospital. This is a robust study aiming to confirm whether lidocaine is a safe and helpful addition to pain relief after major tummy surgery.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

GCS Ramsay Sante Enseignement Et Recherche

Enrolment target

Start

27 Jun 2025

Major patients receiving morphine spinal anaesthesia for major gastrointestinal or abdominal surgery by scheduled laparotomy.

What is this study about?

Imagine you're having a significant operation on your tummy. Afterwards, doctors often use a strong painkiller called morphine, given through a tube into your spine, to keep you comfortable. This study is trying to find an even better way to manage pain and help you recover more smoothly.

Researchers want to see if giving an extra medicine, called lidocaine, through a drip into your arm, can reduce the amount of morphine you need after this type of surgery. They're hoping that if you need less morphine, you might experience fewer side effects that can sometimes come with strong painkillers. The study will compare lidocaine to a 'dummy' medicine (placebo) to see if it truly makes a difference. This means some people will get lidocaine and others will get the dummy medicine, but neither you nor your doctors will know which one you're getting until after the study is over.

The main thing the study will measure is how much morphine you use in the first two days after your operation. They'll also be looking at how well your pain is controlled, how quickly you recover (like when your gut starts working again), how long you stay in hospital, and if you experience any side effects from either the morphine or the lidocaine.

Key takeaways

This study aims to improve pain control after major tummy surgery.
It tests if lidocaine given through a drip can reduce the need for strong morphine painkillers.
Patients will receive either lidocaine or a dummy medicine, alongside their usual pain relief.
The study carefully checks pain levels, morphine use, recovery speed, and any side effects.
It's a 'blinded' study, meaning neither you nor your doctor will know which treatment you receive.

Who may be eligible?

This study is looking for adult patients who are having an important operation on their stomach or digestive system. This type of surgery usually involves a larger cut in the tummy area, known as a laparotomy.

To be considered for this study, you must be receiving morphine for pain relief that is given through a special tube in your spine during and after the surgery. You'll also need to be at least 18 years old.

The study is open to both men and women. There might be some other health checks that your doctor will discuss with you to make sure it's safe for you to take part.

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 major operation on your stomach or digestive system?
Will you be receiving morphine pain relief through a tube in your spine?
Are you comfortable with the idea of potentially receiving a dummy medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either the study medicine (lidocaine) or a placebo (a dummy medicine) through a drip after your surgery. You won't know which one you're getting, and neither will your doctors, until the study is finished. You will still receive your usual morphine pain relief.

During your time in the hospital, nurses and doctors will regularly check your pain levels using a simple scale (from 0 to 10). They will also keep a close eye on how much morphine you are using and ask you about any side effects you might be feeling. The study will track your recovery for up to 96 hours (4 days) after your operation, and will also look at how long you stay in hospital. The total duration of your active involvement in the study's measurements will be until about 4 days after your surgery, although they will note your hospital stay duration.

Potential risks and benefits

Taking part in this study could potentially help doctors understand how to manage pain even better after major surgery, which might lead to better recovery for patients in the future. You might find that you need less morphine or have fewer side effects, but there's no guarantee. As with any medicine, there's always a chance of side effects from lidocaine, and these will be carefully monitored. You will also continue to receive your standard pain relief. You are free 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 is lidocaine?

Lidocaine is a medicine that can be used to numb areas or help with pain, and in this study, it's given through a drip.

What is a 'placebo'?

A placebo is a 'dummy' medicine that looks just like the real medicine but contains no active ingredients. It helps researchers see if the real medicine is actually working.

Will I still get pain relief if I join this study?

Yes, you will still receive your regular morphine pain relief after your surgery, regardless of whether you receive lidocaine or the placebo.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor your doctors will know which one you're receiving during the study. This helps make the study results fair.

How long will the study last for me?

The main part of the study where they monitor you will be for about 4 days after your surgery, but they will also record how long you stay in hospital.