Could a common numbing drug replace opioids after liver surgery?
NCT ID NCT07590830
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 312 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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)
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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.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Centre 01 - CHU de RENNES, Hôpital Pontchaillou
Rennes, 35000, France
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Centre 02 - CH Louis Pasteur, Les Hôpitaux de Chartres
Le Coudray, 28630, France
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Centre 03 - CHU de Clermont-Ferrand, Hôpital Estaing
Clermont-Ferrand, 63100, France
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Centre 04 - Centre Hospitalier Départemental de la Vendée
La Roche-sur-Yon, 85000, France
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Centre 05 - CHU de Lille
Lille, 59000, France
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Centre 06 - Centre Léon Bérard
Lyon, 69008, France
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Centre 07 - CHU Nice, Hôpital Archet 2
Nice, 06200, France
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Centre 08 - AP-HP - Sorbonne Université, Hôpital de la Pitié-Salpêtrière
Paris, 75013, France
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Centre 09 - CHU Toulouse, Hôpital Rangueil
Toulouse, 31400, France
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