AuthorisedTherapeutic use (Phase IV)Interventional

ILHEP : Effect of perioperative Intravenous Lidocaine on postoperative opioid related-side effects after open HEPatectomy: a multicentre prospective randomized controlled study

This study, called ILHEP, is exploring whether giving a common pain medication called lidocaine through a drip during and shortly after liver surgery can help reduce problems generally caused by strong painkillers. These problems can include feeling sick, vomiting, breathing difficulties, or issues with digestion after surgery. Researchers will compare lidocaine to a simple salt solution, which is a standard practice, to see if lidocaine makes a difference. The main goal is to find out if lidocaine can help patients have an easier recovery by reducing these common side effects in the first two days after surgery. This is a large study involving many hospitals to ensure reliable results.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Centre Hospitalier Universitaire De Rennes

Enrolment target

312

Start

10 Mar 2026

Postanesthetic complications in patients undergoing open hepatectomy

What is this study about?

This study, called ILHEP, is looking into how we can make recovery smoother for patients who have had a type of liver surgery called a hepatectomy. After such operations, patients often need strong painkillers, which are very good at controlling pain but can sometimes cause unwanted side effects like feeling sick, vomiting, or having trouble breathing deeply. Another common side effect is a temporary slowdown of the gut, known as ileus, which can delay being able to eat normally.

The main idea behind this study is to see if giving a medicine called lidocaine through a drip, both during and for a short time after the surgery, can help reduce these kinds of problems. Lidocaine is already used in many ways, including as a local anaesthetic to numb areas, but here we’re looking at its potential to help with general recovery after major surgery. The study involves comparing lidocaine with a simple salt solution, which is a common approach in medical research to understand if the treatment works.

Ultimately, the researchers want to find out if patients who receive lidocaine have fewer of these side effects in the first two days after their operation. They will also look at how much pain relief is needed, how long patients stay in hospital, and other aspects of recovery, like the risk of infections. The aim is to improve overall patient comfort and speed up recovery following liver surgery.

Key takeaways

This study is testing if lidocaine can reduce recovery problems after liver surgery.
It aims to lessen sickness, breathing issues, and gut problems caused by strong painkillers.
You would receive either lidocaine or a salt solution through a drip.
Monitoring will focus on the first 48 hours post-surgery and your overall recovery.
The study compares lidocaine to standard care to improve patient comfort.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. Both men and women can take part.

More detailed checks will be done by the study team, but generally, participants will be patients who are due to have an 'open hepatectomy'. This is a specific type of liver surgery where the surgeon makes a cut to access the liver.

It's important to remember that the study is looking at the effects of treatments for potential issues that can happen after this specific surgery. Your doctor or the study team will go through all the specific criteria to make sure the study is right for you.

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.

Am I at least 18 years old?
Am I scheduled for an 'open hepatectomy' (a specific type of liver surgery)?
Am I generally well enough to undergo this type of surgery?
Have I discussed this study thoroughly with my doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the study drug (lidocaine) or a standard salt solution through a drip during your liver surgery and for a short period afterwards. You wouldn't know which one you were receiving, nor would your doctors or nurses, to ensure the results are fair.

The study team would closely monitor you for the first 48 hours after your surgery, looking out for any side effects like sickness, breathing problems, or issues with your digestion. They would also keep track of your pain levels, how much pain relief you need, and how long you stay in hospital.

Apart from receiving the specific drip, there are no extra appointments or tests that are different from standard care after this type of surgery. Your progress would be followed while you are recovering in the hospital, up to 28 days if needed, or until you are discharged.

Potential risks and benefits

Taking part in any study involves careful consideration. Potential benefits might include a smoother recovery from surgery, with fewer side effects like sickness or breathing difficulties, if lidocaine proves effective. However, there's no guarantee it will help every individual, and you might receive the standard salt solution. Like all medications, lidocaine can have potential side effects, although serious reactions are rare when given by trained professionals. The study team will closely monitor you for any issues. You are free to withdraw from the study at any time without 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 an 'open hepatectomy'?

It's a type of liver surgery where the surgeon makes a cut to remove part of the liver.

What is lidocaine and why is it being used?

Lidocaine is a common medicine used to numb areas or help with pain. In this study, it's being explored to see if it can reduce side effects from strong painkillers after surgery.

Will I know if I'm getting lidocaine or the salt solution?

No, neither you nor the doctors will know. This is to make sure the study results are fair and unbiased.

What are 'opioid-related side effects'?

These are problems like feeling sick, vomiting, or breathing difficulties that can sometimes happen when you take strong painkillers called opioids after surgery.

How long will I be monitored for the study?

You will be closely monitored for the first 48 hours after surgery, and your recovery will be followed until you leave the hospital, up to a maximum of 28 days.