LIDOCRIT : Effect of Continuous Intravenous LIDOcaine on Discomfort in Postoperative CRITical Care Inpatients

NCT ID: NCT07043023

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2028-06-01

Brief Summary

Although pain management in intensive care units and intensive care units has improved since the DOLOREA study, research into therapies and techniques to optimise analgesia is still needed. The many adverse effects of morphine are well known, and it has been observed that excessive sedation during the first 48 hours is associated with an increase in mortality and length of stay. Multimodal analgesia protocols, preferably including non-morphine analgesics, could improve the comfort of critical care patients.

Comfort is a central element of critical care and perioperative management, as demonstrated by Patients-Reported Outcomes (PRO), new assessment tools that take into account the patient as a whole. The (Inconfort of REAnimation Patients) IPREA questionnaire, a specific scale for assessing the comfort of critical care patients, is an example of a PRO.

Lidocaine is a voltage-dependent sodium channel blocker, used as a local anaesthetic and antiarrhythmic agent, whose intravenous administration produces analgesic effects, particularly on hyperalgesia. The widely demonstrated clinical benefits in scheduled and major surgery (reduced post-operative pain, reduced doses of anaesthetic agents and opiates, reduced post-operative nausea and vomiting) have led to recommendations for its use. Furthermore, adverse events associated with lidocaine in continuous infusion are minimal.

Based on the early Comfort using Analgesia (eCASH), minimal Sedative and maximal Human care) concepts, the recent PADIS (Pain, Agitation, Delirium, Immobility, Sleep deprivation) recommendations, which determine levels of evidence and research avenues for improving the quality of care, conclude that intravenous lidocaine may be beneficial, but there is a lack of data.

The investigators are therefore proposing a randomised placebo-controlled clinical trial to assess the effectiveness of lidocaine infused continuously for 48 hours on the perceived comfort of post-operative critical care patients, as assessed by the IPREA score.

IPREA, an 18-item score exploring PADIS, is a direct, relevant, objective and reproducible assessment criterion for evaluating algorithms for improving the quality of care. The data on sources of discomfort reveal the importance of pain, dyspnoea, thirst and sleep deprivation, which are all influenced by the analgesia-sedation protocol. Incorporating lidocaine with anti-hyperalgesic properties into the protocol should reduce discomfort in critical care patients.

Detailed Description

The choice of analgesia protocol will be left to the discretion of the clinician between MORPHINE CHLORHYDRATE, SUFENTANIL and REMIFENTANIL for objectives of Behavioral Pain Scale (BPS) (3 to 5) or pain visual analogue scale (VAS) < 4.

The use of co-analgesics intraoperatively (Paracetamol, Nefopam, NSAIDs (nonsteroidal anti-inflammatory drugs) such as Ketoprofen or Ibuprofen, Ketamine) is authorised (data not collected).

If a hypnotic is required intraoperatively, the choice of agent is left to the discretion of the clinician.

Once the sedation-analgesia protocol has been discontinued, pain relief is left to the clinician's discretion.

Patients are monitored from randomisation until discharge from the critical care unit or until a maximum of 30 days post-operatively.

In the event of an adverse reaction linked to lidocaine (see list in § 8.2.), the doctor stops administration of the product.

The blind is lifted (see § 9.2 'Insu (or blinding)'). If the patient is in the lidocaine group, the lidocaine plasma concentration is measured to check for a toxic plasma concentration (see § 5.6 'Management of biological samples').

It should be noted that the completion of an assay or discontinuation of treatment does not result in the patient's withdrawal from the clinical trial. Patient follow-up continues until the end of the trial.

If the patient is discharged from critical care before the 30th post-operative day, the patient's vital status on the 30th post-operative day will be collected.

Conditions

Post-surgery Critical Incare

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lidocaine

Lidocaine 2%, bolus of 0.075 ml/kg real weight (i.e. 1.5 mg/kg) then continuous intravenous administration by electric syringe at 0.05 ml/kg/h (i.e. 1 mg/kg/h) for 48 hours

Group Type: EXPERIMENTAL

Lidocaine (drug)

Intervention Type: DRUG

Lidocaine 2%, bolus of 0.075 ml/kg real weight (i.e. 1.5 mg/kg) then IVSE at 0.05 ml/kg/h (i.e. 1 mg/kg/h) for 48 hours

Placebo

Placebo (sodium chloride 0.9%), bolus of 0.075 ml/kg of real weight then continuous intravenous administration by electric syringe at 0.05 ml/kg/h for 48h

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo (sodium chloride 0.9%), bolus of 0.075 ml/kg of real weight then IVSE at 0.05 ml/kg/h for 48h

Interventions

Lidocaine (drug)

Lidocaine 2%, bolus of 0.075 ml/kg real weight (i.e. 1.5 mg/kg) then IVSE at 0.05 ml/kg/h (i.e. 1 mg/kg/h) for 48 hours

Intervention Type: DRUG

Placebo

Placebo (sodium chloride 0.9%), bolus of 0.075 ml/kg of real weight then IVSE at 0.05 ml/kg/h for 48h

Intervention Type: DRUG

Other Intervention Names

Lidocaine 2%; Sodium chloride 0.9%

Eligibility Criteria

Inclusion Criteria

1. Patient over 18

2. Patient admitted immediately post-operatively in critical care (scheduled or emergency admission, e.g. post-operative exploratory laparotomy, cardiac surgery, major orthopaedic surgery such as polytrauma patients, vascular surgery at risk of complications such as open aortic surgery)

3. Anticipated length of stay in critical care ≥ 48h

4. Membership of a social security scheme

5. Informed consent signed by the patient or by a close relative or legal representative or, failing this, the emergency procedure

1. Weight over 100 kg

2. Hypersensitivity to one of the active substances used for anaesthesia or to one of the excipients.

3. Known acute porphyria,

4. Pregnant or breast-feeding women

5. Patients who have received or are about to receive peri-medullary analgesia intra-operatively or post-operatively.

6. Patient who has received or will receive loco-regional analgesia intra-operatively or post-operatively.

7. Severe head injury, open cephalic neurosurgery, interventional neuroradiology

8. Recovered cardiorespiratory arrest

9. Noradrenaline doses > 0.5 μg/kg/min

10. Stage IV/V chronic renal failure, not on dialysis

11. Severe hepatocellular insufficiency at inclusion (Child-Pugh C)

12. Bradycardia < 50 bpm on antiarrhythmic drugs

13. Clinical convulsive seizure at inclusion

14. Predictable inability to answer the questionnaire (cognitive impairment, non-Francophone)

15. Known participation in another interventional research study (RIPH1 or RIPH2)

16. Known situation of deprivation of liberty or legal protection (safeguard of justice, guardianship or curatorship)

Exclusion Criteria

Patients under court protection will be excluded as soon as the investigator is aware of their status.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elodie MASSERET, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

CHU d'Angers - RCA (Réanimation Chirurgicale A)

Angers, , France

CHU d'Angers - RCB (Réanimation Chirurgicale B)

Angers, , France

CHU de Brest - Réanimation Cardiaque

Brest, , France

CH Louis Pasteur (Chartres) - Réanimation

Chartres, , France

CHU de Nantes - Hôpital Guillaume et René Laennec - Réanimation Chirurgicale Polyvalente

Nantes, , France

CHU de Nantes - Hôpital Guillaume et René Laennec - Réanimation CTCV

Nantes, , France

CHU de Nantes - Hôtel-Dieu - Réanimation chirurgicale

Nantes, , France

CHU de Poitiers - Réanimation Chirurgicale

Poitiers, , France

CHU de Rennes - Réanimation chirurgicale

Rennes, , France

CHU de Rennes - Réanimation CTCV

Rennes, , France

CH de Saint-Nazaire - Réanimation médico-chirurgicale - Unité de Surveillance Continue (USC)

Saint-Nazaire, , France

CHRU de Tours - Hôpital Trousseau - Réanimation Chirurgicale

Tours, , France

CHRU de Tours - Hôpital Trousseau - Réanimation URTC

Tours, , France

CHRU de Tours - Hôpital Trousseau - Unité de Soins Continus

Tours, , France

CH Bretagne Atlantique (Vannes) - Réanimation - Unité de Surveillance Continue

Vannes, , France

Countries

France

Central Contacts

Elodie MASSERET, MD

Role: CONTACT

elodie.masseret@chu-rennes.fr

+33 2 99 28 42 46

Facility Contacts

Sigismond LASOCKI, MD

Role: primary

silasocki@chu-angers.fr

02 41 35 36 35

Emmanuel RINEAU, MD

Role: primary

Emmanuel.Rineau@chu-angers.fr

+33 2 41 35 39 51

Julie LE ROY, MD

Role: primary

julie.leroy@chu-brest.fr

+33 2 98 34 73 31

Juliette AUDIBERT, MD

Role: primary

jaudibert@ch-chartres.fr

+33 2 37 30 30 30

Alice ROUILLARD, MD

Role: primary

Alice.rouillard@chu-nantes.fr

+33 6 62 26 19 92

Côme GAILLARD, MD

Role: primary

Come.gaillard@chu-nantes.fr

+33 2 44 76 86 71

Alexandre BOURDIOL, MD

Role: primary

alexandre.bourdiol@chu-nantes.fr

+33 2 40 08 73 80

Quentin SAINT-GENIS, MD

Role: primary

quentin.saint-genis@chu-poitiers.fr

+33 5 49 44 69 96

Elodie MASSERET, MD

Role: primary

elodie.masseret@chu-rennes.fr

+33 2 99 28 42 46

Grégoire LE GAC, MD

Role: primary

Gregoire.LE.GAC@chu-rennes.fr

+33 2 99 28 85 94

Michel LEMARIE, MD

Role: primary

m.lemarie@ch-saintnazaire.fr

+33 2 72 27 80 00

Mathilde BARBAZ, MD

Role: primary

M.BARBAZ@chu-tours.fr

+33 2 47 47 78 67

Mathilde BARBAZ, MD

Role: primary

M.BARBAZ@chu-tours.fr

+33 2 47 47 78 67

Mathilde BARBAZ, MD

Role: primary

M.BARBAZ@chu-tours.fr

+33 2 47 47 78 67

François MATEOS, MD

Role: primary

francois.mateos@ch-bretagne-atlantique.fr

+33 2 97 01 41 68

Other Identifiers

2024-517749-15-00

Identifier Type: CTIS

Identifier Source: secondary_id

25.00870.000409

Identifier Type: OTHER

Identifier Source: secondary_id

35RC22_8943_LIDOCRIT

Identifier Type: -

Identifier Source: org_study_id