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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Rennes

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Decision date (initial)

2026-03-10

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Direction Générale de l'Offre de Soin (DGOS) - Programme Hospitalier de Recherche Clinique National

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Prophylaxis

To compare the effects of a perioperative lidocaine infusion with that of placebo on postoperative opioid related side effects after open hepatectomy.

Secondary objectives 10

1. Determine the occurrence of postoperative opioid-related adverse event (postoperative opioid-related nausea and vomiting, postoperative opioid-related hypoxemia, postoperative opioid-related ileus and/orpostoperative opioid-related absence of flatus or stools) within the first 48 hours after extubation
2. Determine if lidocaine is associated with a better postoperative analgesia (pain at rest and during movement) within the first 48 hours after extubation
3. Determine if lidocaine can reduce postoperative opioid consumption
4. Determine if lidocaine can reduce the delay to obtain an Aldrete score ≥ 9
5. Determine if lidocaine reduces postoperative rate of unscheduled admission in ICU
6. Determine if lidocaine reduces the length of stay in the hospital
7. Determine if lidocaine reduces the most frequent complications: pneumonia, acute kidney injury, need for reintervention because of a surgical complication and new onset of postoperative atrial fibrillation
8. Determine if lidocaine is associated with a better quality of recovery measured with the QoR40 score
9. Monitore the adverse effects of IV lidocaine
10. Evaluate drug exposure in an ancillary pharmacological study

Conditions and MedDRA coding

Postanesthetic complications in patients undergoing open hepatectomy

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age ≥ 18 years
2. Undergoing a scheduled surgery for open hepatectomy
3. Effective contraception in accordance with CFTG recommendations
4. Having received oral and written information about the protocol and having signed a consent form to take part in this research
5. Affiliated to a social security scheme

Exclusion criteria 14

1. Weight > 100 kg
2. 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
3. Allergy to one of the drugs used for anaesthesia or one of their excipients
4. Nefopam contraindication and, in particular: 1) Renal insufficiency (Creatinine clearance < 50 mL/min) | 2) Inflammatory bowel disease | 3) Allergy
5. Ketoprofen contraindication and, in particular: 1) Untreated glaucoma | 2) Uncontrolled epilepsy | 3) Allergy
6. Urgent surgery
7. Transplant surgery or transplanted patients
8. Surgery with planned regional anaesthesia
9. Patient with a preoperative Sp02 < 95%
10. Obstructive sleep apnoea syndrome
11. Severe hepatic insufficiency (Prothrombin Ratio < 15%)
12. Patient with an ongoing opioid medication that will blur the results
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 hospitalised for a different reason
14. Known participation in other interventional research (RIPH1 or RIPH2)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Composite endpoint defined as the occurrence of a postoperative opioid-related adverse event within the first 48 hours after extubation, like : postoperative nausea and vomiting, postoperative hypoxemia (SpO₂ < 95% requiring oxygen supplementation), or postoperative ileus (intolerance to an oral diet, e.g., soft food or light meal), assessed blinded to the randomization group.

Secondary endpoints 16

1. Occurrence of a postoperative opioid-related nausea and vomiting within the first 48 hours after extubation ; the need for anti-emetic medication will also be recorded
2. Occurrence of a postoperative opioid-related hypoxemia within the first 48 hours after extubation ; the duration of oxygen treatment will also be recorded
3. Occurrence of a postoperative opioid-related ileus within the first 48 hours after extubation
4. Occurrence of a postoperative opioid-related absence of flatus or stools
5. Postoperative pain (numeric rating scale) after extubation at rest and during movement: every 10 minutes in PACU (Post-Anesthesia Care Unit) and every 6 hours until 48 hours after surgery
6. Opioid consumption (mg) during the 48 hours following extubation
7. Time between extubation (H0) and an Aldrete score ≥ 9
8. Rate of unscheduled admission in intensive care unit
9. Hospital length of stay (max 28 days) defined as the number of days after extubation (H0) before first hospital discharge
10. Pneumonia episodes of newly confirmed pneumonia according to the modified CDC criteria within 7 days after surgery or until patient’s discharge from the hospital (max 28 days)
11. Acute kidney insufficiency defined with KDIGO ≥ 2 within 7 days after surgery or until patient’s discharge from the hospital (max 28 days)
12. Need for reintervention because of surgical complication within 7 days after surgery or until patient’s discharge from the hospital (max 28 days)
13. New onset of postoperative atrial fibrillation within 7 days after surgery or until patient’s discharge from the hospital (max 28 days)
14. Quality of recovery measured with the QoR40 score between 24 and 48 hours after extubation
15. Adverse effects of IV experimental treatment
16. Ancillary pharmacological study in 20 patients included in the coordinating centre: plasma lidocaine concentration

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Rennes

Sponsor organisation

Centre Hospitalier Universitaire De Rennes

Address

2 Rue Henri Le Guilloux

City

Rennes Cedex 9

Postcode

35033

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Rennes

Contact name

BELOEIL Hélène

Public contact point

Organisation

Centre Hospitalier Universitaire De Rennes

Contact name

BELOEIL Hélène

Locations

1 EU/EEA country · 9 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications