Not yet recruitingPHASE3INTERVENTIONAL

Efficacy and Safety of Intravenous Lidocaine Versus Placebo in Patients Receiving Morphine-rachi Analgesia

This study is investigating if adding a common pain reliever called lidocaine, given through a vein, can improve pain control after major stomach or bowel surgery. Patients having spinal morphine for pain relief during surgery will either receive lidocaine or a dummy treatment (placebo) through a drip. The main goal is to see if those who receive lidocaine need less morphine for pain relief in the 48 hours after their operation compared to those who get the placebo. This research aims to understand if this combination offers better pain management for individuals undergoing these types of procedures, potentially leading to a smoother recovery.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Enrolment target

Start

01 Apr 2026

Estimated completion

30 Jul 2027

Digestive System Disease Surgery

What is this study about?

Imagine you're having a big operation on your tummy, like surgery on your bowel or liver. Managing pain afterwards is really important for a good recovery. Doctors often use strong pain medicines like morphine, given into your spine, to help with this during and after the surgery.

This study is trying to find out if adding another common pain medicine called lidocaine, given into your vein through a drip, can work even better when combined with the usual spinal morphine. Lidocaine is often used as a local anaesthetic, but it can also help reduce pain when given in this way. The study wants to see if patients who get both lidocaine and spinal morphine need less morphine overall in the two days following their operation compared to those who only get spinal morphine.

By potentially reducing the amount of strong pain medication needed, this could lead to fewer side effects and a more comfortable recovery for patients. This is a "Phase 3" study, which means it's one of the final steps in testing a treatment to see if it's safe and effective before it can be widely used.

Key takeaways

This study compares adding lidocaine to standard spinal pain relief vs. placebo for major tummy surgery.
It aims to see if lidocaine reduces the amount of morphine needed after surgery.
Participants will be randomly assigned to receive either lidocaine or a dummy treatment (placebo) via a drip.
Neither patients nor doctors will know who gets which treatment.
Open tummy surgeries only (laparotomy) are included.
The main observation period is the first 48 hours after surgery.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and be scheduled for a major operation on your digestive system or abdomen (tummy area). This includes surgeries like those on the pancreas, liver, bowel, womb, gullet, or stomach, and it must be done through an open cut using a method called laparotomy. You also need to agree to have morphine given into your spine for pain relief during the operation and be able to provide your informed consent, meaning you understand the study and agree to take part.

There are several reasons why someone might not be able to join. For example, if your surgery is an emergency, you have certain heart or kidney problems, you've had a recent heart attack, or you have severe liver issues. Allergies to morphine or lidocaine would also mean you couldn't take part. Patients with certain nerve conditions, epilepsy, or chronic pain already being managed with strong painkillers would also be excluded.

Additionally, if you are pregnant, might become pregnant and are not using effective contraception, or are breastfeeding, you cannot participate. People who are in another clinical trial, have language or understanding difficulties, are deprived of their liberty, or are under a guardianship order would also not be able to join.

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 over?
Are you having major open surgery on your tummy or digestive system soon?
Are you happy to receive pain relief into your spine (morphine rachi anesthesia)?
Are you NOT pregnant or breastfeeding, and if female, are you using effective contraception?
Do you NOT have serious heart, kidney, or liver problems?
Are you NOT allergic to morphine or lidocaine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned by chance (like flipping a coin) to one of two groups. One group will receive lidocaine through a drip during and after your surgery, along with your spinal morphine. The other group will receive a dummy treatment (placebo) through a drip, along with your spinal morphine. Neither you nor your doctors will know which treatment you are receiving.

The study involves your scheduled major tummy surgery. After your operation, the doctors will carefully monitor how much morphine you need for pain relief for 48 hours. They will also check for any side effects and how you are recovering. There are no extra visits or assessments beyond what would usually be part of your surgery and recovery process. The total duration of your active participation will be for the 48 hours following your surgery, though the study team will follow up on your recovery as part of normal hospital care.

Potential risks and benefits

Potential benefits of taking part could include better pain control after your surgery and possibly needing less strong pain medication like morphine, which might lead to fewer side effects from morphine. However, there's no guarantee you'll personally benefit, as some people will receive the dummy treatment. Like any medical treatment, there are potential risks associated with both lidocaine and morphine, though both are commonly used medicines. The study doctors will monitor you closely for any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Hôpital Privé Jean Mermoz
Verified postcode
Lyon, France

Common questions

What is 'spinal morphine'?

Spinal morphine is a way to give powerful pain relief directly into the fluid around your spinal cord, which is very effective for pain after surgery.

What is a 'placebo'?

A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps ensure we can fairly compare the effects of the actual medicine.

Will I know if I'm getting lidocaine or the placebo?

No, neither you nor your doctors will know whether you are receiving lidocaine or the placebo. This is called 'double-blind' and helps make the study results as fair as possible.

What kind of surgery counts as 'major digestive or abdominal surgery'?

This includes big operations on organs inside your tummy area, such as your liver, pancreas, bowel, stomach, or reproductive organs, specifically when done with an open cut (laparotomy).

How long will I be involved in the study?

Your main involvement in the study will be for the 48 hours after your surgery, during which your pain relief and recovery will be closely monitored as part of the study.

How to find out more

Florent SIGWALT, MD

florent.sigwalt@gmail.com 688620169 Official trial record

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