Could a common numbing drug replace opioids after liver surgery?

NCT ID NCT07590830

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving lidocaine through a vein during and after liver surgery can reduce side effects like nausea, vomiting, and breathing problems caused by opioid painkillers. About 312 adults having planned open liver surgery will be randomly assigned to receive either lidocaine or a placebo. The goal is to see if lidocaine can make recovery smoother and safer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lidocaine
What this could lead to
If it works, this could offer a safer way to manage pain after liver surgery, reducing nausea, vomiting, and breathing problems caused by opioids.
What could go wrong
This is a Phase 4 trial, but lidocaine's benefit for liver surgery specifically is not yet proven. It may not reduce side effects more than placebo, and there are always risks with any drug.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 312 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Inclusion criterion 1 : Age ≥ 18 years * Inclusion criterion 2 : Undergoing a scheduled surgery for open hepatectomy * Inclusion criterion 3 : Effective contraception in accordance with CFTG recommendations * Inclusion criterion 4 : Having received oral and written information about the protocol and having signed a consent form to take part in this research * Inclusion criterion 5 : Affiliated to a social security scheme Exclusion Criteria: * Exclusion criterion 1 : Weight \> 100 kg * Exclusion criterion 2 : Allergy or contraindication to lidocaine or one of its excipients and, in particular: * Known hypersensitivity to lidocaine hydrochloride, to amide-type local anesthetics, or to any of the excipients (sodium chloride, sodium hydroxide solution or concentrated hydrochloric acid solution, water for injection) * Treatment with following antiarythmic medication : class I, class III or Sotalol * Heart failure NYHA grade 3-4, AV-block \>1, without pacemaker * Acute porphyria * Recurrent porphyrias * Uncontrolled epilepsy / Seizure at enrollment * Exclusion criterion 3 : Allergy to one of the drugs used for anaesthesia or one of their excipients * Exclusion criterion 4 : Nefopam contraindication and, in particular: * Renal insufficiency (Creatinine clearance \< 15 mL/min) * Untreated glaucoma * Uncontrolled epilepsy * Allergy * Exclusion criterion 5 : Ketoprofen contraindication and, in particular: * Renal insufficiency (Creatinine clearance \< 50 mL/min) * Inflammatory bowel disease * Allergy * Exclusion criterion 6 : Urgent surgery * Exclusion criterion 7 : Transplant surgery or transplanted patients * Exclusion criterion 8 : Surgery with planned regional anaesthesia * Exclusion criterion 9 : Patient with a preoperative Sp02 \< 95% * Exclusion criterion 10 : Obstructive sleep apnea syndrome * Exclusion criterion 11 : Severe hepatic insufficiency (Prothrombin Ratio \< 15%) * Exclusion criterion 12 : Patient with an ongoing opioid medication that will blur the results * Exclusion criterion 13 : Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty, pregnant or breast-feeding women, minors, persons unable to express their consent, persons hospitalized for a different reason * Exclusion criterion 14 : Known participation in other interventional research (RIPH1 or RIPH2)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hepatectomy are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre 01 - CHU de RENNES, Hôpital Pontchaillou

    Rennes, 35000, France

  • Centre 02 - CH Louis Pasteur, Les Hôpitaux de Chartres

    Le Coudray, 28630, France

  • Centre 03 - CHU de Clermont-Ferrand, Hôpital Estaing

    Clermont-Ferrand, 63100, France

  • Centre 04 - Centre Hospitalier Départemental de la Vendée

    La Roche-sur-Yon, 85000, France

  • Centre 05 - CHU de Lille

    Lille, 59000, France

  • Centre 06 - Centre Léon Bérard

    Lyon, 69008, France

  • Centre 07 - CHU Nice, Hôpital Archet 2

    Nice, 06200, France

  • Centre 08 - AP-HP - Sorbonne Université, Hôpital de la Pitié-Salpêtrière

    Paris, 75013, France

  • Centre 09 - CHU Toulouse, Hôpital Rangueil

    Toulouse, 31400, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.