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

NCT07043023 | Not Yet Recruiting Phase 4

• 3 other identifiers: 35RC22_8943_LIDOCRIT2024-517749-15-0025.00870.000409
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 15

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.

Conditions

Post-surgery Critical Incare

Keywords

critical incare; post-surgery; lidocaine; placebo

Outcome Measures

Primary Outcomes (1)

• IPREA

  Overall score on the Inconforts of Patients in Intensive Care (IPREA) questionnaire. Comfort is assessed by the patient him/herself, using a self-assessment scale IPREA, which is explained and conducted with the medical or paramedical staff in the intensive care unit or intensive care unit. The IPREA questionnaire was developed specifically for critical incare patients. The patient rates his discomfort on a 100 mm graduated visual scale presented horizontally (0: no discomfort, 100: maximum discomfort) for 18 items including (noise, excess light, discomfort of sleeping in intensive care bed, lack of sleep, thirst, hunger, cold, heat, pain, presence of pipes, lack of privacy, anxiety, isolation, limitation of visits, absence of telephone, lack of information, difficulty breathing, depression). The overall score is calculated from the average of each item, giving a score from 0 (minimum discomfort) to 100 (maximum discomfort).

  Within 24 hours of discharge from critical care or, failing that, within 24 hours of the 15th day of hospitalisation in critical care.

Secondary Outcomes (12)

• IPREA - Sensitivity analysis of the main criterion

  Within 24 hours of discharge from critical care or, failing that, within 24 hours of the 15th day of hospitalisation in critical care.

• IPREA

  Within 24 hours of discharge from critical care or, failing that, within 24 hours of the 7th day of hospitalisation in critical care

• IPREA - 8 items

  Within 24 hours of discharge from critical care or, failing that, within 24 hours of the 15th day of hospitalisation in critical care.

• Cumulative opioid consumption

  Over the first 6 post-surgery days

• Duration of invasive mechanical ventilation

  Until discharge from critical care, including, in the event of transfer, the stay in critical care in the transfer hospital, or, failing this, until day 30

Study Arms (2)

Lidocaine

EXPERIMENTAL

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

Drug: Lidocaine (drug)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Lidocaine (drug) 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

Also known as: Lidocaine 2%

Lidocaine

Placebo 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

Also known as: Sodium chloride 0.9%

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over 18
• 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)
• Anticipated length of stay in critical care ≥ 48h
• Membership of a social security scheme
• Informed consent signed by the patient or by a close relative or legal representative or, failing this, the emergency procedure
• Weight over 100 kg
• Hypersensitivity to one of the active substances used for anaesthesia or to one of the excipients.
• Known acute porphyria,
• Pregnant or breast-feeding women
• Patients who have received or are about to receive peri-medullary analgesia intra-operatively or post-operatively.
• Patient who has received or will receive loco-regional analgesia intra-operatively or post-operatively.
• Severe head injury, open cephalic neurosurgery, interventional neuroradiology
• Recovered cardiorespiratory arrest
• Noradrenaline doses \> 0.5 μg/kg/min
• Stage IV/V chronic renal failure, not on dialysis

You may not qualify if:

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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (15)

CHU d'Angers - RCA (Réanimation Chirurgicale A)

Angers, 49933, France

Location

CHU d'Angers - RCB (Réanimation Chirurgicale B)

Angers, 49933, France

Location

CHU de Brest - Réanimation Cardiaque

Brest, 29200, France

Location

CH Louis Pasteur (Chartres) - Réanimation

Chartres, 28630, France

Location

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

Nantes, 44093, France

Location

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

Nantes, 44093, France

Location

CHU de Nantes - Hôtel-Dieu - Réanimation chirurgicale

Nantes, 44093, France

Location

CHU de Poitiers - Réanimation Chirurgicale

Poitiers, 86021, France

Location

CHU de Rennes - Réanimation chirurgicale

Rennes, 35033, France

Location

CHU de Rennes - Réanimation CTCV

Rennes, 35033, France

Location

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

Saint-Nazaire, 44600, France

Location

CHRU de Tours - Hôpital Trousseau - Réanimation Chirurgicale

Tours, 37170, France

Location

CHRU de Tours - Hôpital Trousseau - Réanimation URTC

Tours, 37170, France

Location

CHRU de Tours - Hôpital Trousseau - Unité de Soins Continus

Tours, 37170, France

Location

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

Vannes, France

Location

MeSH Terms

Interventions

Lidocaine; Pharmaceutical Preparations; Sodium Chloride

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Elodie MASSERET, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elodie MASSERET, MD

CONTACT

+33 2 99 28 42 46; elodie.masseret@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The syringes are prepared by a 'friendly' service (not involved in the patient's follow-up) and are of identical format whatever the experimental treatment, in order to maintain blindness. The randomisation arm is not known to the doctor in charge of the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomised, multicentre, double-blind, placebo-controlled clinical trial. Comparison of Lidocaine IVSE to placebo. Randomisation by block in 1:1, stratified according to centre. All patients were randomised as soon as possible and within 6 hours of leaving the operating theatre, into one of two groups: * Experimental group: 2% Lidocaine, bolus of 0.075 ml/kg of 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. * Control group: placebo (sodium chloride 0.9%), bolus of 0.075 ml/kg real weight then IVSE at 0.05 ml/kg/h for 48 hours Treatment is started as soon as possible, up to 2 hours after randomisation. The syringes were prepared by a 'friendly' service (not involved in patient follow-up) and were of identical size to maintain blindness. The randomisation arm was not known to the doctor in charge of the patient.

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 29, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15)