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ILHEP : Effect of perioperative Intravenous Lidocaine on postoperative opioid related-side effects after open HEPatectomy: a multicentre prospective randomized controlled study
EU CTIS ID: 2025-522462-73-00
What this study is testing
To compare the effects of a perioperative lidocaine infusion with that of placebo on postoperative opioid related side effects after open hepatectomy.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Undergoing a scheduled surgery for open hepatectomy
- Effective contraception in accordance with CFTG recommendations
- Having received oral and written information about the protocol and having signed a consent form to take part in this research
- Affiliated to a social security scheme
You likely can't join if
- Weight > 100 kg
- Obstructive sleep apnoea syndrome
- Severe hepatic insufficiency (Prothrombin Ratio < 15%)
- Patient with an ongoing opioid medication that will blur the results
- 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 hospitalised for a different reason
- Known participation in other interventional research (RIPH1 or RIPH2)
See the full eligibility criteria
- Age ≥ 18 years
- Undergoing a scheduled surgery for open hepatectomy
- Effective contraception in accordance with CFTG recommendations
- Having received oral and written information about the protocol and having signed a consent form to take part in this research
- Affiliated to a social security scheme
- Weight > 100 kg
- Obstructive sleep apnoea syndrome
- Severe hepatic insufficiency (Prothrombin Ratio < 15%)
- Patient with an ongoing opioid medication that will blur the results
- 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 hospitalised for a different reason
- Known participation in other interventional research (RIPH1 or RIPH2)
- Allergy or contra-indication to lidocaine or one of its excipients and, in particular: 1) Treatment with following antiarythmic medication : class I, class III or Sotalol | 2) Heart failure NYHA grade 3-4, AV-block >1, without pacemaker | 3) Acute porphyria | 4) Uncontrolled epilepsy / Seizure at enrollment
- Allergy to one of the drugs used for anaesthesia or one of their excipients
- Nefopam contraindication and, in particular: 1) Renal insufficiency (Creatinine clearance < 50 mL/min) | 2) Inflammatory bowel disease | 3) Allergy
- Ketoprofen contraindication and, in particular: 1) Untreated glaucoma | 2) Uncontrolled epilepsy | 3) Allergy
- Urgent surgery
- Transplant surgery or transplanted patients
- Surgery with planned regional anaesthesia
- Patient with a preoperative Sp02 < 95%
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.